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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE; DEFIB/PACING ELECTRODE
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BIO-DETEK INCORPORATED PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE; DEFIB/PACING ELECTRODE Back to Search Results
Model Number 8900-4006
Device Problem Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.User medwatch received: please refer to the user medwatch report that zoll medical has received.
 
Event Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), a pop noise was heard when the associated device delivered energy using these electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
 
Manufacturer Narrative
The customer was contacted for return of the suspect product.The product has not been returned to zoll for evaluation.
 
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Brand Name
PRO-PADZ RADIOLUCENT SOLID GEL ELECTRODE, SINGLE
Type of Device
DEFIB/PACING ELECTRODE
Manufacturer (Section D)
BIO-DETEK INCORPORATED
525 narragansett park drive
pawtucket RI 02861
MDR Report Key12450510
MDR Text Key272148665
Report Number1218058-2021-00115
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00847946016661
UDI-Public00847946016661
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/24/2022
Device Model Number8900-4006
Device Catalogue Number8900-4006
Device Lot Number1721D
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received08/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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