• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-DETEK INCORPORATED ELECTRODES, MFE, PRO-PADZ, BIPHASIC AUTOMATED EXTERNAL DEFIBRILLATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIO-DETEK INCORPORATED ELECTRODES, MFE, PRO-PADZ, BIPHASIC AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number 9600-0127
Device Problems Sparking (2595); Patient Device Interaction Problem (4001)
Patient Problem Burn(s) (1757)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
 
Event Description
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), after removing the electrode pads, burns were found on the patient's skin and an spark was seen from the electrode pads. Complainant indicated that the patient subsequently sustained a burn. The customer was unable to provide information on the degree of the burn.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameELECTRODES, MFE, PRO-PADZ, BIPHASIC
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
BIO-DETEK INCORPORATED
525 narragansett park drive
pawtucket RI 02861
Manufacturer Contact
525 narragansett park drive
pawtucket, RI 02861
4017291400
MDR Report Key12192168
MDR Text Key262431256
Report Number1218058-2021-00094
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number9600-0127
Device Catalogue Number9600-0127
Device Lot Number1521B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/19/2021 Patient Sequence Number: 1
-
-