MAUDE Adverse Event Report: DORNOCH EVAC STATION; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number ULEV100

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).A follow-up mdr will be submitted once the investigation has been completed.

Event Description

Evac station drain pump was smoking and burning the belt.There was no patient involvement.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous repair record for ultra evacuation unit 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.On (b)(6) 2018, it was reported from (b)(6) hospital (b)(6) that the drain pump was smoking and burning the belt.(b)(4) was contacted about the cart and dispatched a service technician to be at the site.On (b)(4) 2018, the technician found that the drain pump was malfunctioning.He replaced the drain pump (part # 70077, lot code 0026922) and 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.Service work order (b)(4) on (b)(4) 2018.Although the reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the drain pump was replaced, it cannot be determined from the information provided what caused the drain pump to fail.Therefore, the root cause could not be determined.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.External contractor.

Event Description

No additional event information was received.

• Brand Name: EVAC STATION
• 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: 7897651
• MDR Text Key: 121014401
• Report Number: 0001954182-2018-00062
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133786
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULEV100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1