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

Model Number N/A

Device Problems Device Emits Odor (1425); Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

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.

• Brand Name: TRANSPOSAL SAFETY STATION NON-STERILE
• Type of Device: APPARATUS, 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 Key: 6798548
• MDR Text Key: 83685840
• Report Number: 0001954182-2017-00016
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TPSS100
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1