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

Catalog Number ULEV100

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Dhr/repair history review: the previous repair record for ultra evac unit serial number (b)(4) is 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.Technical review and physical evaluation: on 16 october 2019, it was reported that the unit was unable to connect with any carts, there are exposed wires at the base of the coupler head, and she suspects that the handle is broken.The zimmer biomet authorized service technician from dynamic biomedical arrived at the site on 17 october 2019, evaluated the unit and confirmed the reported event.After that he replaced coupler kit for the unit and confirmed that the unit was functioning as intended.The unit was tested, inspected, and repaired.Probable cause/root cause: although the reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after replacing coupler, it cannot be determined from the information provided why the coupler head was damaged.Therefore, the root cause could not be determined for reported event.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Conclusion: review of the information provided during the investigation determined there is no further actions needed at this time.This complaint is determined not to be a new confirmed quality or manufacturing issue and this complaint will be tracked and trended.Complaint trending procedure for any adverse trends that may warrant further action.

Event Description

It was reported that the unit was unable to connect with any carts.There are exposed wires at the base of the coupler head, and it was suspected that the handle was broken.The event timing was during cleaning and did not result in any harm or injury.No adverse events were reported as a result of this malfunction.

• 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: 9295793
• MDR Text Key: 207033098
• Report Number: 0001954182-2019-00072
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ULEV100
• Device Lot Number: 0023155
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2016
• 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