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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. POWER PUMP DP ARTHROSCOPE

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ZIMMER BIOMET, INC. POWER PUMP DP ARTHROSCOPE Back to Search Results
Model Number N/A
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The complaint was confirmed based on the evaluation of the returned device. The dhr and service records of this pump were reviewed. No nonconformances that could have led to this hazard were identified. The pump met/passed all test and inspection specifications at the time of release. Root cause is related to operational context/maintenance deficiency, as this device had not been calibrated since (b)(6) 2013. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that the unit malfunctioned, showing multiple pressure error codes. The unit was found at a facility and was noted to be repaired. No patient or procedure impact was reported. No additional information was provided.
 
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Brand NamePOWER PUMP DP
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key8378653
MDR Text Key137427869
Report Number0001825034-2019-00885
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093409
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number941010
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2013
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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