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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO PADZ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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BIO-DETEK INCORPORATED PRO PADZ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 8900-4006
Device Problem Device Emits Odor (1425)
Patient Problem Burn, Thermal (2530)
Event Date 01/24/2020
Event Type  malfunction  
Event Description
This is the second time an event has occurred with the pro-padz in use with a cardioversion patient. First patient also in pacu for cardioversion. After cardioversion and on removal of pads, there was noted to be a small burn on patients chest along the edge of where pad was, approx 1. 5 cm long, 1mm wide. Second event is being submitted now that we have set of pads, cardioversion was successful after one attempt. Removed anterior defib pad a burning smell was noted. Patient had red circular marks on her chest in shape of the pads as well. No skin appeared blistered or burned. A mole in center of chest was bleeding but was quickly stopped. Manufacturer response for adult multi-function electrodes pro-padz, pro-padz (per site reporter). Director of cardiology is reaching out to their representative.
 
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Brand NamePRO PADZ
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
BIO-DETEK INCORPORATED
269 & 271 mill road
chelmsford MA 01824
MDR Report Key9705847
MDR Text Key179241798
Report Number9705847
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
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8900-4006
Device Catalogue Number8900-4006
Device Lot Number5119
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/27/2020
Event Location No Information
Date Report to Manufacturer02/13/2020
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

Patient Treatment Data
Date Received: 02/13/2020 Patient Sequence Number: 1
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