LUCAS ® CPR CHEST COMPRESSION SYSTEM
Report
- Report Number
- 3005445717-2024-00001
- Event Type
- Death
- Date Received
- January 15, 2024
- Date of Event
- December 15, 2023
- Report Date
- June 11, 2024
- Manufacturer
- JOLIFE AB - 3005445717
- Product Code
- DRM
- UDI-DI
- 00883873834329
- PMA / PMN Number
- K173553
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
CORRECTED DATA: SECTION H11, ADDITIONAL MFG NARRATIVE OF THE INITIAL MEDWATCH REPORT INDICATES: "A STRYKER FIELD SERVICE REPRESENTATIVE PERFORMED AN INITIAL EVALUATION OF THE CUSTOMER¿S DEVICE AND WAS NOT ABLE TO DUPLICATE THE REPORTED ISSUE. HOWEVER, THE STRYKER FIELD SERVICE REPRESENTATIVE OBSERVED THAT AN ERROR HAD BEEN LOGGED OUT AND FOUND A CREASE ON THE COMMUNICATION CABLE BETWEEN THE PROTECTIVE AND CONTROL BOARDS. THIS CABLE WAS REPLACED TO RESOLVE THE REPORTED ISSUE. AFTER COMPLETING OTHER UNRELATED REPAIRS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE."
SECTION G3, REPORTABILITY AWARENESS DATE OF THE INITIAL MEDWATCH REPORT INDICATES: 01/09/2024; SECTION G3, REPORTABILITY AWARENESS DATE OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: 12/15/2023.
A STRYKER FIELD SERVICE REPRESENTATIVE PERFORMED AN INITIAL EVALUATION OF THE CUSTOMER¿S DEVICE AND WAS NOT ABLE TO DUPLICATE THE REPORTED ISSUE. HOWEVER, THE STRYKER FIELD SERVICE REPRESENTATIVE OBSERVED THAT AN ERROR HAD BEEN LOGGED OUT AND FOUND A CREASE ON THE COMMUNICATION CABLE BETWEEN THE PROTECTIVE AND CONTROL BOARDS. THIS CABLE WAS REPLACED TO RESOLVE THE REPORTED ISSUE. AFTER COMPLETING OTHER UNRELATED REPAIRS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. STRYKER CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. THE CUSTOMER PROVIDED STRYKER WITH THE AVAILABLE PATIENT INFORMATION. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. STRYKER PERFORMED A CLINICAL REVIEW REGARDING THE REPORTED ISSUE. AND, IT WAS OBSERVED THAT THE DEVICE USE MAY HAVE CONTRIBUTED TO THE EVENT. IT WAS CONSIDERED AND USER ERROR BECAUSE WHEN THE DEVICE STOPPED TO FUNCTION, THE RESCUER STARTED MANUAL CPR AFTER ABOUT 30 S AND THIS IS NOT ACCORDING TO THE INSTRUCTION FOR USE, MANUAL CPR SHOULD BE STARTED IMMEDIATELY.
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD STOPPED COMPRESSIONS DURING PATIENT'S CARE. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD STOPPED COMPRESSIONS DURING PATIENT'S CARE. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.
A CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE HAD STOPPED COMPRESSIONS DURING PATIENT'S CARE. IF A DEVICE MALFUNCTIONS, THE DEVICE OPERATING INSTRUCTIONS INDICATE THAT THE USER IS TO REMOVE THE DEVICE AND IMMEDIATELY START MANUAL CHEST COMPRESSIONS. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 829784 | LUCAS ® CPR CHEST COMPRESSION SYSTEM | COMPRESSOR, CARDIAC, EXTERNAL | DRM | JOLIFE AB - 3005445717 | LUCAS | 00883873834329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Death |