LIFEPAK(R) 1000 DEFIBRILLATOR
Report
- Report Number
- 0003015876-2018-01767
- Event Type
- Death
- Date Received
- October 23, 2018
- Date of Event
- October 2, 2018
- Report Date
- January 14, 2020
- Manufacturer
- PHYSIO-CONTROL, INC. - 3015876
- Product Code
- MKJ
- UDI-DI
- 00885074698878
- PMA / PMN Number
- K122600
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
SECTION G4 OF SUPPLEMENTAL MEDWATCH REPORT 002 INDICATES: 8/20/2019. SECTION G4 OF SUPPLEMENTAL MEDWATCH REPORT 002 SHOULD INDICATE: 11/25/2019. SECTION G4 OF THIS SUBMISSION WILL REMAIN 01/14/2020 SO AS NOT TO CREATE A LATE SUBMISSION.
PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE CUSTOMER'S BATTERY WAS UNABLE TO LOCK EASILY INTO THE CUSTOMER'S DEVICE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE CUSTOMER'S BATTERY, HOWEVER FURTHER CAUSE COULD NOT BE DETERMINED. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CUSTOMER WAS PROVIDED WITH A NEW BATTERY.
DEATH DATE OF THE INITIAL MEDWATCH REPORT WAS BLANK. DEATH DATE OF THE INITIAL MEDWATCH REPORT SHOULD BE "(B)(6) 2018".
OUTCOMES ATTRIBUTED TO THE AE OF THE INITIAL MEDWATCH REPORT WAS BLANK. OUTCOMES ATTRIBUTED TO THE AE OF THE INITIAL MEDWATCH REPORT SHOULD BE "DEATH".
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THE BATTERY INDICATOR OF THE DEVICE WAS FLASHING BUT THE DEVICE WOULD NOT POWER ON. ANOTHER AMBULANCE UNIT WAS ON THE SCENE AND USED ANOTHER DEVICE AND WAS ABLE TO TREAT THE PATIENT. THE CUSTOMER DID NOT KNOW THE DELAY BETWEEN THE USE OF THE ORIGINAL DEVICE AND THE BACKUP DEVICE. AFTER THE EVENT WHEN THEY CUSTOMER WAS BACK AT THEIR OFFICE, THE DEVICE DISPLAYED ¿OK¿ AND THE BATTERY WAS FULLY CHARGED. THEY REMOVED THE BATTERY TO GET THE BATTERY INFORMATION, WHEN ATTEMPTING TO REINSTALL THE BATTERY THEY FELT THAT IT WAS VERY DIFFICULT TO SLIDE THE BATTERY INTO THE BATTERY COMPARTMENT. THE PATIENT, AN 81 YEAR OLD MALE DID NOT SURVIVE.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THE BATTERY INDICATOR OF THE DEVICE WAS FLASHING BUT THE DEVICE WOULD NOT POWER ON. ANOTHER AMBULANCE UNIT WAS ON THE SCENE AND USED ANOTHER DEVICE AND WAS ABLE TO TREAT THE PATIENT. THE CUSTOMER DID NOT KNOW THE DELAY BETWEEN THE USE OF THE ORIGINAL DEVICE AND THE BACKUP DEVICE. AFTER THE EVENT WHEN THEY CUSTOMER WAS BACK AT THEIR OFFICE, THE DEVICE DISPLAYED ¿OK¿ AND THE BATTERY WAS FULLY CHARGED. THEY REMOVED THE BATTERY TO GET THE BATTERY INFORMATION, WHEN ATTEMPTING TO REINSTALL THE BATTERY THEY FELT THAT IT WAS VERY DIFFICULT TO SLIDE THE BATTERY INTO THE BATTERY COMPARTMENT. THE PATIENT, AN 81 YEAR OLD MALE DID NOT SURVIVE.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THE BATTERY INDICATOR OF THE DEVICE WAS FLASHING BUT THE DEVICE WOULD NOT POWER ON. ANOTHER AMBULANCE UNIT WAS ON THE SCENE AND USED ANOTHER DEVICE AND WAS ABLE TO TREAT THE PATIENT. THE CUSTOMER DID NOT KNOW THE DELAY BETWEEN THE USE OF THE ORIGINAL DEVICE AND THE BACKUP DEVICE. AFTER THE EVENT WHEN THEY CUSTOMER WAS BACK AT THEIR OFFICE, THE DEVICE DISPLAYED ¿OK¿ AND THE BATTERY WAS FULLY CHARGED. THEY REMOVED THE BATTERY TO GET THE BATTERY INFORMATION, WHEN ATTEMPTING TO REINSTALL THE BATTERY THEY FELT THAT IT WAS VERY DIFFICULT TO SLIDE THE BATTERY INTO THE BATTERY COMPARTMENT. THE PATIENT, AN 81 YEAR OLD MALE DID NOT SURVIVE.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THE BATTERY INDICATOR OF THE DEVICE WAS FLASHING BUT THE DEVICE WOULD NOT POWER ON. ANOTHER AMBULANCE UNIT WAS ON THE SCENE AND USED ANOTHER DEVICE AND WAS ABLE TO TREAT THE PATIENT. THE CUSTOMER DID NOT KNOW THE DELAY BETWEEN THE USE OF THE ORIGINAL DEVICE AND THE BACKUP DEVICE. AFTER THE EVENT WHEN THEY CUSTOMER WAS BACK AT THEIR OFFICE, THE DEVICE DISPLAYED ¿OK¿ AND THE BATTERY WAS FULLY CHARGED. THEY REMOVED THE BATTERY TO GET THE BATTERY INFORMATION, WHEN ATTEMPTING TO REINSTALL THE BATTERY THEY FELT THAT IT WAS VERY DIFFICULT TO SLIDE THE BATTERY INTO THE BATTERY COMPARTMENT. THE PATIENT, AN 81 YEAR OLD MALE DID NOT SURVIVE.
(B)(4). PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED PATIENT EVENT AND WAS UNABLE TO DETERMINE IF THE DEVICE USE CONTRIBUTED TO THE PATIENT OUTCOME. THIS WAS BECAUSE OF INSUFFICIENT INFORMATION AVAILABLE, DUE TO THE LACK OF THE PATIENT ECG RECORD FOR THE EVENT TO DETERMINE IF THE ECG RHYTHM WAS SHOCKABLE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. THE CUSTOMER ADVISED THAT THE BATTERY INDICATOR OF THE DEVICE WAS FLASHING BUT THE DEVICE WOULD NOT POWER ON. ANOTHER AMBULANCE UNIT WAS ON THE SCENE AND USED ANOTHER DEVICE AND WAS ABLE TO TREAT THE PATIENT. THE CUSTOMER DID NOT KNOW THE DELAY BETWEEN THE USE OF THE ORIGINAL DEVICE AND THE BACKUP DEVICE. AFTER THE EVENT WHEN THE CUSTOMER WAS BACK AT THEIR OFFICE, THE DEVICE DISPLAYED ¿OK¿ AND THE BATTERY WAS FULLY CHARGED. THEY REMOVED THE BATTERY TO GET THE BATTERY INFORMATION, WHEN ATTEMPTING TO REINSTALL THE BATTERY THEY FELT THAT IT WAS VERY DIFFICULT TO SLIDE THE BATTERY INTO THE BATTERY COMPARTMENT. THE PATIENT, (B)(6) YEAR OLD MALE DID NOT SURVIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837968 | LIFEPAK(R) 1000 DEFIBRILLATOR | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | PHYSIO-CONTROL, INC. - 3015876 | 1000 | 00885074698878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death |