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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH EVAC STATION APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH EVAC STATION APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010900
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 10/14/2019
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). Evaluation and investigation is in process. Once the investigation is complete, a supplemental medwatch will be filed. Evaluated by external contractor.

 
Event Description

It was reported that during cleaning the unit was found to have a broken coupler handle where wires had been pulled out of the coupler boot, exposing bare 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)
DORNOCH
200 northwest parkway
riverside MO 64150
Manufacturer (Section G)
DORNOCH
200 northwest parkway
riverside MO 64150
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key9272959
MDR Text Key194610519
Report Number0001954182-2019-00071
Device Sequence Number1
Product Code JCX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK162421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00514010900
Device LOT Number0027695
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/03/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/24/2018
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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