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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number ULDU500
Device Problem Incorrect Measurement (1383)
Patient Problem No Patient Involvement (2645)
Event Date 12/10/2018
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This investigation is being completed per as no problem was found.Therefore, the complaint history and dhr reviews are not required.On (b)(6) 2018 it was reported from (b)(6) that the unit was not reading the correct volume.On (b)(6) 2018, (b)(4) was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and was unable to confirm that the unit was reading the volume incorrectly.The technician verified that the unit was functioning as intended.The technician then returned the unit to service without further incident.Service work order (b)(4) on (b)(6) 2018.The root cause for the reported volume issue could not be determined as the technician was unable to replicate the reported event.The technician inspected the device and noted that it was functioning as intended.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
Event Description
It was reported that the unit was not reading correct volume amount.The event occurred during prior to surgery.No adverse events were reported as a result of this malfunction.
 
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Brand Name
ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
Type of Device
APPARATUS, 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 Key8210255
MDR Text Key131923832
Report Number0001954182-2019-00002
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133786
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberULDU500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/10/2018
Initial Date FDA Received01/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberN/A
Patient Sequence Number1
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