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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH SUCTION PUMP

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RICHARD WOLF GMBH SUCTION PUMP Back to Search Results
Model Number 2208011
Device Problem Computer Software Problem
Event Date 06/25/2019
Event Type  Malfunction  
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Brand NameSUCTION PUMP
Type of DeviceSUCTION PUMP
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimer street 32
knittlingen, 75438
GM  75438
Manufacturer (Section G)
RICHARD WOLF GMBH
pforzheimer street 32
knittlingen, 75438
GM  75438
Manufacturer Contact
oliver ehrlich
pforzheimer street 32
knittlingen,  75438
  75438
MDR Report Key8833477
Report Number1418479-2019-00032
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 07/26/2019,06/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2208011
Device Catalogue Number2208011
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/26/2019
Distributor Facility Aware Date06/27/2019
Event Location Hospital
Date Report TO Manufacturer07/26/2019
Date Manufacturer Received07/12/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/26/2019 Patient Sequence Number: 1
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