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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 ULEV100
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2019
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). Dhr/repair history review: the previous repair record for ultra evac unit serial number (b)(4) is reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair. The previous repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed. Technical review and physical evaluation: on 16 october 2019, it was reported that the unit was unable to connect with any carts, there are exposed wires at the base of the coupler head, and she suspects that the handle is broken. The zimmer biomet authorized service technician from dynamic biomedical arrived at the site on 17 october 2019, evaluated the unit and confirmed the reported event. After that he replaced coupler kit for the unit and confirmed that the unit was functioning as intended. The unit was tested, inspected, and repaired. Probable cause/root cause: although the reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after replacing coupler, it cannot be determined from the information provided why the coupler head was damaged. Therefore, the root cause could not be determined for reported event. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time. This complaint is determined not to be a new confirmed quality or manufacturing issue and this complaint will be tracked and trended. Complaint trending procedure for any adverse trends that may warrant further action.

 
Event Description

It was reported that the unit was unable to connect with any carts. There are exposed wires at the base of the coupler head, and it was suspected that the handle was broken. The event timing was during cleaning and did not result in any harm or injury. 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 Key9295793
MDR Text Key207033098
Report Number0001954182-2019-00072
Device Sequence Number1
Product Code JCX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133786
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 11/07/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULEV100
Device LOT Number0023155
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 Received10/16/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/20/2016
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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