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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH TRANSPOSAL SAFETY STATION NON-STERILE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH TRANSPOSAL SAFETY STATION NON-STERILE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number N/A
Device Problems Device Emits Odor; Failure to Power Up
Event Date 02/02/2017
Event Type  Malfunction  
Manufacturer Narrative

The complaint is being reported by zimmer biomet as (b)(4). Device problem: "device emits odor" is for burning smell. The previous repair report for the transposal safety station, serial (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair. The reported event was confirmed by the service technician who performed the repair. Gse bio-medical services was contacted about the cart and dispatched a service technician to be at the site. The technician found that booster pump was leaking and main fuse was shorted. He replaced the fuse and the booster pump then verified that the device was functioning as intended. The unit was then returned to service without incident. The unit was tested, inspected, and repaired. While the service technician confirmed that the unit was having a burning smell due to booster pump leak as well as a short main fuse and noted that the cart was functioning as intended after the technician replaced the fuse and the booster pump, it cannot be determined from the information provided what actually caused the reported event. Therefore, based on the information provided, a specific root cause of the reported event cannot be determined. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Product evaluated by external contractor.

 
Event Description

It was reported that the safety station has had a burning smell for some time. It shut down during a cycle and would not power back on. No adverse events have been reported as a result of the malfunction.

 
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Brand NameTRANSPOSAL SAFETY STATION NON-STERILE
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 Key6798548
Report Number0001954182-2017-00016
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 08/16/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/16/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberTPSS100
Device LOT NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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