POWERHEART G5 KIT, AUTO, INTL ENG
Received Oct 16, 2023
Report 2112020-2023-00931 · MDR key 17939906
Device
Generic name
Automated External Defibrillator
Manufacturer
Cardiac Science CorporationModel number
G5A-00ACatalog number
G5A-00A
Lot number
NA
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "RED X" INDICATOR. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Additional Manufacturer Narrative
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A SUPPLEMENTAL REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE ACTIVITY LOG. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING INCLUDING FUNCTIONALITY TESTING WITHOUT DUPLICATING THE REPORT. INTERNAL INSPECTION OF THE DEVICE FOUND NO DISCREPANCIES. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Additional Manufacturer Narrative
THIS SUPPLEMENTAL MEDWATCH REPORT UPDATES INFORMATION BASED UPON YOUR REQUEST WHICH DIFFERS FROM THE INITIAL MEDWATCH REPORT FILED. PLEASE REFERENCE SECTIONS D4 CATALOG # REMOVED, D4 PRIMARY UDI # UPDATED.