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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ PULSE-GENERATOR, PACEMAKER, EXTERNAL

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BIO-DETEK INCORPORATED PRO PADZ PULSE-GENERATOR, PACEMAKER, EXTERNAL Back to Search Results
Model Number 8900-4006
Device Problem Sparking (2595)
Patient Problem Insufficient Information (4580)
Event Date 11/17/2020
Event Type  malfunction  
Event Description
Patient had cardioversion and during the cardioversion a spark was seen from the defib pads.
 
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Brand NamePRO PADZ
Type of DevicePULSE-GENERATOR, PACEMAKER, EXTERNAL
Manufacturer (Section D)
BIO-DETEK INCORPORATED
269 & 271 mill road
chelmsford MA 01824
MDR Report Key10867776
MDR Text Key217135748
Report Number10867776
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8900-4006
Device Catalogue Number8900-4006
Device Lot Number3820A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/18/2020
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer11/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/19/2020 Patient Sequence Number: 1
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