• 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 PRO-PADZ LIQUID GEL RADIOLUCENT MFE ELECTRODE

  • 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 PRO-PADZ LIQUID GEL RADIOLUCENT MFE ELECTRODE Back to Search Results
Model Number 8900-2106-01
Device Problem Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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 cardioverting a patient (age & gender unknown), sparking was seen coming from the electrode pads. Complainant indicated that there was no adverse effect to the patient due to the reported malfunction. Please reference medwatch report number 1218058-2019-00167 for a similar report from the same customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRO-PADZ LIQUID GEL RADIOLUCENT MFE
Type of DeviceELECTRODE
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 Key9444379
MDR Text Key170062880
Report Number1218058-2019-00166
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,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/21/2020
Device Model Number8900-2106-01
Device Catalogue Number8900-2106-01
Device Lot Number4319A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-