Eight emails and two comments later, your Editor wonders why the full court press on TTA. Our Readers may have noted that at the end of our last article on Best Buy [TTA 25 June] and their expansion into digital health, there was a brief reference to a recall of their subsidiary GreatCall’s Lively Mobile Plus and a related lawsuit:
This is not without pitfalls. Earlier this month, Best Buy was sued for a defect found in its GreatCall Lively MobilePlus mobile PERS that in action failed to detect falls as described, after GreatCall discontinued the device in mid-May in what a letter from their CEO David Inns described as an “important safety recall,” offering buyers a Jitterbug flip phone or a full refund.
The link above was to a fairly comprehensive 3 June article in Mobihealthnews on a Federal District Court-Central District of California class action lawsuit filed by firm Bisnar Chase on 22 May on behalf of plaintiff Scott Barnes of San Luis Obispo, California (document via Mobihealthnews).
- Mr. Barnes purchased the device on 21 April.
- In early May, Mr. Barnes fell twice but the device did not detect the fall and automatically alert emergency services. Mr. Barnes is a disabled veteran and relied on the device to detect falls. The lawsuit states that he suffered unspecified damages as a result.
- In a letter from David Inns as we noted above, GreatCall notified purchasers/subscribers dated 15 May (letter) that it was recalling all devices. It acknowledged fault in a quality issue. It also asked customers to stop using the device immediately and return it for a full refund plus additional considerations.
More on this is from a Morning Call (Allentown PA) article (picked up from the San Diego Union-Tribune) provided by Mr. Barnes to this Editor. It makes the cogent point that the device as a PERS did not require FDA 510(k) clearance. Fall detection does not fall under Class I or II medical device regulation as it does not monitor vital signs.
Mr. Barnes has written five separate emails to this Editor within less than ten minutes, with another three after our reply. Obviously, this matter is important to him. Moreover, our email is public and we welcome direct contact (including confidential contact) from our Readers with pertinent information. We also welcome comments on articles and don’t mind it being lively.
However, there were two comments at the end of our earlier article on Best Buy’s acquisition of Critical Signal Technologies that are, in the opinion of this Editor, marginal. One from ‘Scott’ implied that there was a relationship between this publication and Best Buy: “What is your companies relationship with the Recalled Great Call/Best Buy Mobile Lively Plus defective device that is now under a Federal Legal Action and Lawsuits.” (My answer was, of course, is that we report on these two companies, and other than that, have no relationship.) The other from ‘Kennie’ was phrased as ‘Be Warned’ and made certain assertions about the device and the company which have yet to be proved in court. This was published with some trepidation.
We ask commenters to be respectful of other Readers, of the facts, and understand that we report–and comment–as we see it.