HS1+ (W G) DEFIB, JAPANESE, EXCHG
Received Aug 3, 2023
Report 3030677-2023-03099 · MDR key 17455188
Device
Product problems
- Failure of Device to Self-Test
- Failure of Device to Self-Test
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ON ORIGINAL FINAL REPORT 3030677-2023-03099, THE COMPONENT CODE GRID WAS NOT UPDATED NOR WAS THE INVESTIGATION SUMMARY INCLUDED. PLEASE REFERENCE BELOW FOR THE FINDINGS AND THE UPDATED COMPONENT GRID: THE HS1 DEVICE (SN: (B)(6)) WAS RETURNED TO PHILIPS FOR ADDITIONAL ANALYSIS. THE COMPLAINT WAS ESCALATED FOR TECHNICAL COMPLAINT INVESTIGATION AND THE RESULTS INDICATE THAT COMPONENT WAS RECEIVED IN GOOD CONDITION WITHOUT ACCESSORIES. EXTERNAL VISUAL INSPECTION NOTED NO ANOMALIES. IN THE FA LAB, THE DEVICE POWERED UP NORMALLY, AND PRIOR TO TESTING, THE PATIENT, SYSTEM AND DEVICE RECORD (PSDR) WAS EXTRACTED. THE DEVICE RECORD SHOWED SELF-TESTS ABORTED DUE TO ¿CARTRIDGE_LID_OPEN.¿ INDICATIVE OF A DEFECTIVE PROXIMITY SWITCH. A BATTERY INSERTION TEST (BIT) WAS ATTEMPTED BUT WOULD NOT RUN. TROUBLESHOOTING WAS CONDUCTED AND RESULTED IN THE PROXIMITY SENSOR/SWITCH BEING FOUND TO BE OPEN. THIS DEFECTIVE COMPONENT WAS REPLACED, AND THE DEVICE PASSED ALL ATTEMPTED BITS WITH NO ISSUES REPORTED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A PROXIMITY SENSOR / SWITCH FOUND TO BE OPEN. THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, NO FURTHER ACTION IS NECESSARY AT THIS TIME. THE CUSTOMER WAS PROVIDED A REPLACEMENT DEVICE TO RESOLVE THE ISSUE. IT HAS BEEN CONCLUDED THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.
Description of Event or Problem
IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE IS FAILING SELF-TEST.