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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
Model Number N/A
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 01/31/2020
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). Once an evaluation of the device is completed, a follow-up/final report will be submitted.

 
Event Description

It was reported that during cleaning, this device was discovered to have a torn boot and exposed wires. There was no patient involvement. No adverse events were reported as 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 Key9677614
MDR Text Key194601796
Report Number0001954182-2020-00006
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 03/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00514010900
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 Received03/19/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/02/2017
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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