Catalog Number 293001-001 |
Device Problems
Device Displays Incorrect Message (2591); Noise, Audible (3273)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/12/2014 |
Event Type
malfunction
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Event Description
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The reported issue involves the syncardia companion 2 driver and two companion external batteries and are reported under three separate medical device reports: companion 2 driver s/n (b)(4) (mfr report #3003761017-201-00283); companion external battery s/n (b)(4); and companion external battery s/n (b)(4) (mfr report #3003761017-2014-00287).The customer reported that the companion 2 driver displayed an "emergency battery low" alarm and all battery indicator lights were red while supporting a patient.The customer also reported that the companion 2 driver "emergency battery low" alarm resolved within seconds and all companion external battery lights were green.
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Manufacturer Narrative
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This alleged failure mode poses a low risk to the patient because it did not prevent the companion 2 from performing its life-sustaining functions.The companion 2 drier and companion batteries will be returned to syncardia for evaluation.The results of the investigation will be provided in supplemental mdrs.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The reported issue involves the syncardia companion 2 driver and two companion external batteries and are reported under three separate medical device reports: (1) companion 2 driver s/n (b)(4) (mfr report # 3003761017-2014-00283); (2) companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00286); and (3) companion external battery s/n (b)(4) (mfr report # 3003761017-2014-00287).The customer reported that the companion 2 driver displayed an "emergency battery low" alarm and all battery indicator lights were red while supporting a patient.The customer also reported that the companion 2 driver "emergency battery low" alarm resolved within seconds and all companion external battery lights were green.Companion external battery s/n (b)(4) was returned as a precautionary measure, to determine if it could have contributed to the root cause of the "emergency battery low" alarm reported in companion 2 driver s/n (b)(4) (mfr report # 3003761017-2014-00283).An investigation was conducted and the root cause of the customer reported alarm was a malfunction of the power management piston cylinder assembly (pca) on the companion 2 driver.Review of the incoming inspection record for the external battery revealed no anomalies.The battery met all manufacturing procedures and incoming inspection criteria prior to being placed in finished goods.A visual and mechanical inspection of the battery was performed and no physical anomalies were found.The battery was tested in accordance with (b)(4), companion external battery evaluation procedure, and passed all final performance testing.The battery performed as intended, and there was no evidence of a malfunction.The investigation confirmed that the battery was not the root cause of the customer reported "emergency battery low" alarm as described in mfr report # 3003761017-2014-00283.The battery met all inspection and testing acceptance criteria and will be returned to service.
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Search Alerts/Recalls
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