MalfunctionNAA
NA
Received Aug 11, 2022 · Event occurred Jul 21, 2022
Report 3008642652-2022-22029 · MDR key 15210775
Device
Generic name
E-belt
Manufacturer
Zoll Manufacturing CorporationProduct problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE REPORTED PROBLEM (CONNECTOR DAMAGED) HAS BEEN CONFIRMED. UPON INVESTIGATION THE TRUNK CABLE CONNECTOR WAS PHYSICALLY DAMAGED AND THE ELECTRODE BELT WAS UNABLE TO SECURELY CONNECT TO A MONITOR. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED BELT.
Description of Event or Problem
A US DISTRIBUTOR REPORTED THAT A PATIENT'S ELECTRODE BELT WAS DAMAGED.