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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HCU 30 BASE UNIT; HCU 30 BASE UNIT 100-120 V
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MAQUET CARDIOPULMONARY AG HCU 30 BASE UNIT; HCU 30 BASE UNIT 100-120 V Back to Search Results
Model Number 70103.4371
Device Problems Electrical /Electronic Property Problem (1198); Failure to Power Up (1476)
Patient Problem No Patient Involvement (2645)
Event Date 01/08/2015
Event Type  malfunction  
Event Description
It was reported that the unit would not power up after completing a cleaning mode cycle.No pt involvement.Ref: # (b)(4).
 
Manufacturer Narrative
A maquet field svc tech investigated the unit and reset the 20 amp breaker as well as the 12 amp breaker.The unit was tested to factory spec.All tests were performed successfully.Verified sys was fully functional and a ice block was made prior to placing the unit back in service.A supplemental medwatch will be submitted if add'l info becomes available.
 
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Brand Name
HCU 30 BASE UNIT
Type of Device
HCU 30 BASE UNIT 100-120 V
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
Manufacturer Contact
michael campbell
kehler strabe 31
rastatt 76437
GM   76437
2229321132
MDR Report Key4491414
MDR Text Key5568638
Report Number8010762-2015-00049
Device Sequence Number1
Product Code DWC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031544
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/08/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number70103.4371
Device Catalogue Number70103.4371
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/08/2015
Initial Date FDA Received02/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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