• 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, MFE, RADIOLUCENT, ADULT DEFIB/PACING 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, MFE, RADIOLUCENT, ADULT DEFIB/PACING ELECTRODE Back to Search Results
Model Number 8900-4005
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Information (3190)
Event Type  Malfunction  
Manufacturer Narrative

Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.

 
Event Description

Complainant alleged that during an electrophysiology case with a (b)(6) female patient, the electrode pads would not adhere to the patient's skin. Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRO PADZ, MFE, RADIOLUCENT, ADULT
Type of DeviceDEFIB/PACING ELECTRODE
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 Key8232266
MDR Text Key133342027
Report Number1218058-2018-00118
Device Sequence Number1
Product Code DTE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK960676
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/09/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date07/09/2019
Device MODEL Number8900-4005
Device Catalogue Number89004005
Device LOT Number2818A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-