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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG; HL 20 CONSOLE BASE
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MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG; HL 20 CONSOLE BASE Back to Search Results
Catalog Number 70102.7652
Device Problem Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported, while performing a function check a clicking sound occured that was not present initially.After operating unit overnight at full 250 rpm's clicking ceased.Upon disassembly i noticed that (upper) belt was twisted and the (lower) belt was broken.(b)(4).
 
Manufacturer Narrative
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device, maquet cardiopulmonary (b)(4).Pump product number: mcp00703309.Pump serial number: (b)(4).The actual device has not been evaluated yet.A supplemental medwatch will be submitted upon receipt of additional info.Items marked ni are unknown to us at this time.
 
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Brand Name
MAQUET CARDIOPULMONARY AG
Type of Device
HL 20 CONSOLE BASE
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM 
Manufacturer Contact
michael campbell
kehler strasse 31
rastatt 76437
GM   76437
2229321132
MDR Report Key4620299
MDR Text Key18067700
Report Number8010762-2015-00255
Device Sequence Number1
Product Code DPW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K943803
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number70102.7652
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Event Location Hospital
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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