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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL LEVEL 1; ELECTRONIC ASSEMBLY 115V TRAUMA
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NULL LEVEL 1; ELECTRONIC ASSEMBLY 115V TRAUMA Back to Search Results
Catalog Number 7012701
Device Problem Circuit Failure (1089)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information was received that device quit working.New part was ordered and installed-received same message.No patient injury occurred.
 
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Brand Name
LEVEL 1
Type of Device
ELECTRONIC ASSEMBLY 115V TRAUMA
Manufacturer (Section G)
NULL
MDR Report Key10200758
MDR Text Key196602500
Report Number3012307300-2020-06269
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number7012701
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/28/2020
Initial Date FDA Received06/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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