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

Catalog Number ULEV100

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is being evaluated by an external contractor and the investigation is in process.Once the investigation is completed, a supplemental report will be filed accordingly.

Event Description

It was reported that in the cleaning unit there was a belt inside that wants to turn it on to connect it to the suction machine but it smelled like burning.The event time is during cleaning.This complaint was opened to address the other occurrences since the customer states "it has been happening for about a week".No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).The previous repair record for ultra evacuation unit serial number 33232 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 28 january 2019, it was reported from (b)(6) hospital and medical center that an evac unit was producing a burning smell.The complaint was created to address the other occurrences due to the work order stating that the reported event had occurred for about a week.On 28 january 2019, nsn was contacted about the unit and attempted to contact the account for a purchase order.On 01 february 2019 and 06 february 2019, nsn attempted to contact the account again in order to dispatch a technician.The or front desk attempted to contact someone at the account to provide a po.On 08 february 2019, the account had not responded, so the work order was subsequently closed.Per crm, a repair checklist was not required.Service work order dms-49455-x9q9q1 on 28 january 2019.Because a technician was never dispatched to inspect the device, the reported event was never confirmed.Because of this, it is not known with the information provided what led to the occurrence of the reported event.Therefore, based on the information available, the specific root cause 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.

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
• MDR Report Key: 8361849
• MDR Text Key: 136875798
• Report Number: 0001954182-2019-00017
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K123188
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1