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U.S. Department of Health and Human Services

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

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DORNOCH EVAC STATION APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010900
Device Problem Material Frayed (1262)
Patient Problem No Patient Involvement (2645)
Event Date 10/11/2019
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded under zimmer biomet complaint number (b)(4). On 11 october 2019, river city electric llc was contacted about the cart and dispatched a service technician to be at the site. The technician arrived at the site and found that the coupler was not functioning and the boot was slid down, exposing inner wires. The coupler handle itself was not broken. He noted that the coupler itself was not getting power from the control board. When he lifted the evac¿s lid he found an insect lying dead on the control board across the fuses. He swapped the fuses with spares, but the board had indeed failed. He returned on 17 october 2019 and replaced the control board (part #70065 and lot code #0041683) and then verified that the unit was functioning as intended. The technician then returned the unit to service without further incident. The device was tested, inspected, and repaired. The root cause for the unit not connecting to carts was due to a failed control board. The control board oversees the electrical functions of the unit; the board failing such as what the technician observed would result in the coupler not being able to connect to carts. In addition, the reported event of the coupler handle being damaged was not confirmed as the handle was confirmed to not be damaged. Therefore, a specific root cause of the coupler handle damage report cannot be determined. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the control board was replaced. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Based on the information provided, this investigation determined that there is no need for further action (ie/capa/scar/hhe/d) at this time. This complaint will be tracked and trended for any adverse trends that may require additional actions.

 
Event Description

It was reported that the unit had a damaged coupler handle and would not connect to the carts. The event timing was during cleaning and did not result in any harm or injury. During the investigation, exposed wires were identified. No adverse events have been reported as a result of this malfunction.

 
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Brand NameEVAC STATION
Type of DeviceAPPARATUS, 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 Key9310429
MDR Text Key188723702
Report Number0001954182-2019-00073
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 11/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00514010900
Device LOT Number0026623
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 Received11/07/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/02/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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