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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number N/A
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2020
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). Udi #: (b)(4). Product review of the duo fluid cart serial number (b)(4) by zimmer biomet certified service repair technician on may 05, 2020 revealed that the unit had vacuum issue, vacuum sensor 2 errors. One of the vacuum pump fuses was bad. The fuse was replaced but the vacuum pump still would not run. While removing the capacitor for replacement, the vacuum pump wires were damaged. Repair of the device was performed by zimmer biomet certified service repair technician on may 05, 2020 which included replacement of the following: item# 70098, lot# 0042839, intellicart vacuum pump kit. Review of the device history record(s) identified no deviations or anomalies during manufacturing. Device is used for treatment. Reported event is not related to a combination of products; therefore, a compatibility review is not applicable. Review of complaint history identified additional similar complaints for the reported item(s)/part family and no additional complaints for the reported part and lot combination(s). Complaints are monitored through monthly complaint review in order to identify potential adverse trends. A definitive root cause cannot be determined. No corrective actions, preventive actions, or field actions resulted after investigation of this event. The event is confirmed.

 
Event Description

It was reported before surgery that the unit had vacuum issues, vacuum sensor 2 errors. During an investigation of the device, frayed/bared wires were discovered. No adverse events were reported as a result of this malfunction.

 
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Brand NameDUO FLUID CART
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 Key10119025
MDR Text Key200012424
Report Number0001954182-2020-00022
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 06/04/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00514010100
Device LOT Number0040347
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/03/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2019
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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