MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. TRANSPOSAL SAFETY STATION; WASHER OF BODY WASTE RECEPTACLES

Model Number N/A

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Device emits odor: there was a burning smell from the unit.Customer has indicated that the product will not be returned to zimmer biomet for investigation, but will be evaluated by an external contractor.Once the investigation has been completed, a follow up mdr will be submitted.

Event Description

It was reported that the unit had a burning smell and was not powering on.The event occurred during cleaning.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.The following sections were updated/corrected.The previous repair record for transposal safety station serial number (b)(4) was 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.The reported event was confirmed by the service technician who performed the repair per cl-repair tpss rev 4.On (b)(6) 2017, it was reported from (b)(6) that the unit has a burning smell and is not powering on.Crawford diversified services, inc.Was contacted about the cart and dispatched a service technician to be at the site.On (b)(6) 2017, the technician found bleach flow sensor smoking, led on pressure transducer is not lighting up and right canister is still not working.He replaced the bleach flow sensor (part#91220), right canister switch (part#90060 and lot code#0025836) and canister switch board and then verified that the device was functioning as intended.The cart was then returned to service without incident.The unit was tested, inspected, and repaired as per cl-repair tpss rev.4.Service work order (b)(4) on (b)(6) 2017.The root cause of the reported event of burning smell from the unit was due to bleach flow sensor smoking and the root cause of the reported event of unit not powering on was due to malfunctioned led on pressure transducer.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after bleach flow sensor, right canister switch and canister switch board were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.The replacement of the canister switch and canister switch board were not affiliated with the reported event.

• Brand Name: TRANSPOSAL SAFETY STATION
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7010887
• MDR Text Key: 92211770
• Report Number: 0001526350-2017-00835
• Device Sequence Number: 1
• Product Code: FLH
• 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,Followup
• Report Date: 12/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• 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