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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. EVAC STATION APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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ZIMMER SURGICAL, INC. EVAC STATION APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number ULEV100
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 01/24/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Once an investigation of the device is completed, a follow-up/final report will be submitted.

 
Event Description

It was reported that there was a hole in the coupler hose and there were exposed wires. No adverse events were reported as a result of this malfunction.

 
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Brand NameEVAC STATION
Type of DeviceAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key9644008
MDR Text Key195141216
Report Number0001526350-2020-00112
Device Sequence Number1
Product Code JCX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK123188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULEV100
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured10/30/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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