MAQUET CARDIOPULMONARY AG MAQUET HCU30 DEVICE; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Model Number 70103.4642 |
Device Problem
Maintenance Does Not Comply To Manufacturers Recommendations (2974)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/31/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A maquet field service technician will investigate and repair the device.A supplemental medwatch will be submitted when additional information becomes available.
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Event Description
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"no/low cooling capacity, no ice in the tank." the incident occurred during maintenance / service, no patient was involved.(b)(4).
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Manufacturer Narrative
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(b)(4).The device was investigated by the service engineer at the depot.He could not repair the device there, so it was returned to the manufacturing site.The compressor, the main heater, the potentiometer and the bottom cover were all replaced.Function and safety tests were carried out as per service protocols.All tests passed and the device was shipped back to the customer.The customer has confirmed that the unit is functioning properly and that there are no problems.There was no patient involvement.
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Event Description
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(b)(4).
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Search Alerts/Recalls
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