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

Catalog Number 00514010900

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4).Once the investigation is complete, a follow up/final report will be submitted.

Event Description

It was reported that during cleaning, the unit smelled hot when processing a cart.There were no smoke/sparks as a result of this malfunction and there was no harm involved.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Udi#: (b)(4).There were no problems found with the unit and no allegations of harm.This meets the criteria for a limited investigation.Therefore, the dhr review is not required.On 17 september 2019, it was reported from (b)(6) medical center that the unit smelled hot when processing a cart.On 17 september 2019, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site.On 17 september 2019, the technician arrived at the site but was unable to duplicate the reported concern.The technician verified that the unit was functioning as intended then returned the unit to service without further incident.The reported event could not be confirmed during inspection of the device; therefore, the root cause for the unit smelling hot could not be determined.The device was noted to be functioning as intended and no problem was found.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

No additional information available.

• 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: 9111942
• MDR Text Key: 199709254
• Report Number: 0001954182-2019-00060
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• PMA/PMN Number: K162421
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00514010900
• Device Lot Number: 0040583
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1