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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH POWER MODULE FOR TRAUMA RECON SYSTEM; BATTERY, REPLACEMENT, RECHARGEABLE
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SYNTHES GMBH POWER MODULE FOR TRAUMA RECON SYSTEM; BATTERY, REPLACEMENT, RECHARGEABLE Back to Search Results
Catalog Number 05.001.202
Device Problems Failure to Charge (1085); Complete Loss of Power (4015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2022
Event Type  malfunction  
Event Description
It was reported from singapore that during service and evaluation, it was determined that the power module device was showing a service led, would not charge, did not function, the device stopped by itself, and had fluid ingress.It was further determined that the device failed pretest for information button and self-test, charging and checking of power module in charger ubc ii, function test, saw test, and check the liquid indicator.It was noted in the service order that the device was not charging and there was a trace of opening it.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device stopped by itself.Therefore, the reported condition that the device was not charging was confirmed.He reported condition of service led was not confirmed.The assignable root cause was determined to be traced to the user, which is user error.Udi ¿ (b)(4).
 
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Brand Name
POWER MODULE FOR TRAUMA RECON SYSTEM
Type of Device
BATTERY, REPLACEMENT, RECHARGEABLE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kara ditty-bovard
eimattstrasse 3
oberdorf 4436
SZ   4436
6107428552
MDR Report Key13713477
MDR Text Key295330667
Report Number8030965-2022-01478
Device Sequence Number1
Product Code MOQ
UDI-Device Identifier07611819977822
UDI-Public07611819977822
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05.001.202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2022
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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