FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
MDR report key: 7877219
·
Received September 14, 2018
Report
- Report Number
- 0003015876-2018-01525
- Event Type
- Malfunction
- Date Received
- September 14, 2018
- Date of Event
- August 17, 2018
- Report Date
- September 14, 2018
- Manufacturer
- PHYSIO-CONTROL, INC. - 3015876
- Product Code
- MKJ
- UDI-DI
- 00883873979426
- PMA / PMN Number
- K142430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE. PHYSIO DETERMINED THE CAUSE OF THE REPORTED ISSUE WAS DUE TO LOOSE KEP NUTS FOR THE BATTERY PINS. AFTER TIGHTENING THE KEP NUTS FOR THE BATTERY PINS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF AND ON BY ITSELF DURING A PATIENT EVENT. THIS OCCURRED DURING A 3 LEAD ECG AND MONITORING THE PATIENT. PHYSIO-CONTROL CONTACTED THE CUSTOMER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT BOTH THE PATIENT AND THE EVENT, HOWEVER, NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 718067 | LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | PHYSIO-CONTROL, INC. - 3015876 | 15 | 00883873979426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |