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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH EVAC STATION POWERED SUCTION PUMP

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DORNOCH EVAC STATION POWERED SUCTION PUMP Back to Search Results
Model Number 00-5140-109-00
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 11/19/2019
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). The previous repair record for intellicart 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. The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed. On (b)(6) 2019, a zimmer biomet certified service repair technician was contacted about the cart and dispatched to be at the site. On (b)(6) 2019, the technician arrived at the site and confirmed that the unit had a fluid leak; there was a split in the peristaltic tubing. The technician replaced the peristaltic pump hose (part #90058) and leak detector (pn 70088, lot 0041658) then noted the bootstrap on the coupler was torn. He replaced the coupler (pn 70029, lot 0041784) then found carts were not communicating. He then replaced the control board (pn 70065, lot 0040666) then verified that the evac was functioning as intended. The technician then returned the evac to service without further incident. The device was tested, inspected, and repaired. The root cause for the unit leaking was due to a torn peristaltic pump hose. The peristaltic pump hose transports fluid through the unit to the drain pump. A split in the tubing can allow fluid to leak, as seen in the reported event. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the peristaltic pump hose and additional components were replaced. 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 per trending procedure for any adverse trends that may warrant further action.

 
Event Description

It was reported that during cleaning the evac was leaking and did not result in harm or delay. There were exposed wires. No adverse events were reported as a result of this malfunction.

 
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Brand NameEVAC STATION
Type of DevicePOWERED SUCTION PUMP
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 Key9636098
MDR Text Key194601790
Report Number0001954182-2020-00005
Device Sequence Number1
Product Code JCX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK162421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 01/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number00-5140-109-00
Device Catalogue Number00514010900
Device LOT Number0026679
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/05/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

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