Analysis of the returned device identified a greenish/black foreign residue on the inside of the device.It appears that at some point this liquid ran freely inside and throughout the device resulting in electrical and mechanical malfunctions.The greenish/black foreign residue appears to be a cleaning agent (like (b)(6)) that was used on the device and got into the compression module resulting in the observed device problems and the reason for this mdr.On october 9, 2019, we reached out to the customer to inquire about their cleaning procedures and to review the findings our investigation; specifically, the residue found in the arm compression module.We spoke with (b)(6) who confirmed they use (b)(6) which is green industrial degreaser to clean the arm after an event.We advised him of the cleaning requirements of this device as specified in the device labeling.Later that afternoon, we received a follow-up call from (b)(6), from the same company, who stated, contrary to what was reported by (b)(6), that they clean the arm with (b)(6) disinfectant wipes & (b)(6).
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It was reported by a professional user that a rescue team went to use the device during a rescue and after performing a couple of compression cycles, the device stopped performing compressions and the warning indicator and warning light went on.The rescue team stopped the device, repositioned it on the patient, restarted the device and after the device stopped a second time, the rescue team removed the device from the patient and provided manual cpr to the patient who survived.No additional patient or event information was provided.
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