MAUDE Adverse Event Report: DORNOCH TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE; WASHER OF BODY WASTE RECEPTACLES

Catalog Number TPSS100

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been documented under zimmer biomet complaint number (b)(4).The device is being evaluated by an external contractor and investigation is in process.Once the investigation is completed, a follow up medwatch will be filed accordingly.

Event Description

It was reported that the unit would not power on and there was an electrical burning smell coming from unit.The event occurred during cleaning.No adverse events have been reported as a result of this malfunction.

Manufacturer Narrative

On 14 december 2018, it was reported from (b)(6) hospital that a unit would not power on and there was an electrical burning smell coming from the unit.On 14 december 2018, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.The technician arrived at the site but could not confirm that the unit would not power on or that there was a burning smell.The tech plugged the unit in and ran a cycle, and found that the flow sensor needed replaced.He replaced the flow sensor (part #91220) and then verified that the cart was functioning as intended.The technician then returned the cart to service without further incident.The device was tested, inspected, and repaired.Service work order (b)(4) on 14 december 2018.The reported event could not be confirmed during inspection of the device, therefore the root cause of the unit not powering on and the electrical burning smell could not be determined.The device was noted to be functioning entirely as intended after the flow sensor was replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

Event Description

No additional event information.

• Brand Name: TRANSPOSAL SAFETY STATION NON-STERILE INSTRUCTIONS FOR USE
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): DORNOCH; 200 northwest parkway; riverside MO 64150
• MDR Report Key: 8232417
• MDR Text Key: 133086683
• Report Number: 0001954182-2019-00004
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TPSS100
• Device Lot Number: 0021788
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1