LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
Report
- Report Number
- 0003015876-2022-02068
- Event Type
- Death
- Date Received
- September 19, 2022
- Date of Event
- August 25, 2022
- Report Date
- March 16, 2023
- Manufacturer
- PHYSIO-CONTROL, INC. - 3015876
- Product Code
- MKJ
- PMA / PMN Number
- K130454
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
(B)(6). STRYKER CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. THE CUSTOMER INFORMED STRYKER THAT NO FURTHER PATIENT INFORMATION IS AVAILABLE. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. THOUGH STRYKER REQUESTED SOME PATIENT INFORMATION, STRYKER WILL NOT REQUEST ANY INFORMATION WHICH CAN IDENTIFY, DIRECTLY OR INDIRECTLY, A PERSON TO BE IN ACCORDANCE WITH REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL. STRYKER REQUESTED ADDITIONAL INFORMATION REGARDING DISPOSITION OF THE DEVICE AND AVAILABILITY OF THE ELECTRONIC PATIENT RECORDS. CLINICAL REVIEW WILL BE PERFORMED FOR THE REPORTED EVENT. STRYKER 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. NOT RETURNED TO MANUFACTURER.
SECTION H6 METHOD CODE GRID OF SUPPLEMENTAL MDR INDICATES: DEVICE NOT RETURNED; ANALYSES OF PRODUCTION RECORDS. SECTION H6 METHOD CODE GRID OF SUPPLEMENTAL MDR SHOULD INDICATE: DEVICE NOT RETURNED; COMMUNICATION/INTERVIEWS.
STRYKER PERFORMED CLINICAL REVIEW OF THE REPORTED EVENT AND CONCLUDED THAT DEVICE CONTRIBUTION TO THE REPORTED EVENT WAS UNKNOWN. THERE WERE INSUFFICIENT DATA WITHIN THE FILE TO DETERMINE THE IMPACT OF THE DEVICE USE TO THE PATIENT OUTCOME. THE CUSTOMER CONFIRMED THAT THE DEVICE WILL NOT BE RETURNED FOR THE EVALUATION AS THEY CONCLUDED THAT THE INCIDENT OCCURRED DUE TO USER ERROR.
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO DELIVER A SHOCK WHILE USING INTERNAL PADDLES DURING INTERVENTION ON A PATIENT. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THE PATIENT DID NOT SURVIVE REPORTED EVENT. THE HEALTHCARE PROVIDER WAS NOT ABLE TO CONFIRM IF THE DEVICE USE CONTRIBUTED TO THE PATIENT OUTCOME.
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO DELIVER A SHOCK WHILE USING INTERNAL PADDLES DURING INTERVENTION ON A PATIENT. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THE PATIENT DID NOT SURVIVE REPORTED EVENT. THE HEALTHCARE PROVIDER WAS NOT ABLE TO CONFIRM IF THE DEVICE USE CONTRIBUTED TO THE PATIENT OUTCOME.
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE FAILED TO DELIVER A SHOCK WHILE USING INTERNAL PADDLES DURING INTERVENTION ON A PATIENT. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO PROVIDE DEFIBRILLATION THERAPY, IF IT WERE NEEDED. THE PATIENT DID NOT SURVIVE REPORTED EVENT. THE HEALTHCARE PROVIDER WAS NOT ABLE TO CONFIRM IF THE DEVICE USE CONTRIBUTED TO THE PATIENT OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2521952 | LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | PHYSIO-CONTROL, INC. - 3015876 | 20E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |