HEARTSINE GATEWAY 500P BUNDLE SALES BOM - UK ENGLISH
Report
- Report Number
- 3004123209-2025-00022
- Event Type
- Malfunction
- Date Received
- January 28, 2025
- Date of Event
- January 3, 2025
- Report Date
- December 18, 2025
- Manufacturer
- HEARTSINE TECHNOLOGIES LTD
- Product Code
- MKJ
- PMA / PMN Number
- P160008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
SECTION G1 REPORTING ENTITY OF SUPPLEMENTAL MDR INDICATES: PHYSIO-CONTROL, INC. - 3015876 SECTION G1 REPORTING ENTITY OF SUPPLEMENTAL MDR SHOULD INDICATE: HEARTSINE TECHNOLOGIES LTD SECTION G1 MANUFACTURING SITE FOR DEVICES OF SUPPLEMENTAL MDR INDICATES: PHYSIO-CONTROL, INC. - 3015876 SECTION G1 MANUFACTURING SITE FOR DEVICES OF SUPPLEMENTAL MDR SHOULD INDICATE: HEARTSINE TECHNOLOGIES LTD.
THE CUSTOMER'S DEVICE WAS RETURNED FOR THE EVALUATION. A SERVICE REPRESENTATIVE WAS ABLE TO DUPLICATE THE REPORTED ISSUE. A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.
THE CUSTOMER'S DEVICE WAS NOT RETURNED FOR EVALUATION. A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.
HEARTSINE HAS REQUESTED RETURN OF THE DEVICE FOR INVESTIGATION. UPON COMPLETION, THE CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW-UP REPORT. THE PAD-PAK-03 DEVICE IS NOT AVAILABLE FOR DISTRIBUTION IN THE UNITED STATES BUT IS SIMILAR TO THE PAD-PAK-01 WHICH IS DISTRIBUTED IN THE UNITED STATES.
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR PAD-PAK WAS DEPLETED BEFORE EXPIRY AND COULD NOT POWER ON ANY SAM PAD DEVICES. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR PAD-PAK WAS DEPLETED BEFORE EXPIRY AND COULD NOT POWER ON ANY SAM PAD DEVICES. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR PAD-PAK WAS DEPLETED BEFORE EXPIRY AND COULD NOT POWER ON ANY SAM PAD DEVICES. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR PAD-PAK WAS DEPLETED BEFORE EXPIRY AND COULD NOT POWER ON ANY SAM PAD DEVICES. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2376764 | HEARTSINE GATEWAY 500P BUNDLE SALES BOM - UK ENGLISH | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | HEARTSINE TECHNOLOGIES LTD | PAD-PAK-03 | H1108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |