Model Number MCP00706035#ROTAFLO |
Device Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).
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Event Description
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(b)(4).It was reported a head error occurred.A patient involvement was not reported.
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Event Description
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Internal reference: (b)(4).Customer reference: (b)(4).
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Manufacturer Narrative
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Data corrected in section d.A rotaflow drive with article number 701022161 and serial number (b)(6) was provided in the initial report but this was made by mistake.The correct device is provided in section d now.A getinge field service technician was on side to check the device in question.After conversation with the ssu on 2019-09-11 the rotaflow console with s/n (b)(4) was not affected.The reason being the initial service request called in by the customer was for the s/n of the console.Once the issue was determined to be the drive head the second complaint (b)(4) was created rotaflow console has no problem therefore no work has performed on this device.Thus the failure could not be confirmed.Most probable root cause could not be determined, because no failure was detected.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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Search Alerts/Recalls
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