HEARTSTART XL+ DEFIBRILLATOR/MONITOR
Report
- Report Number
- 3030677-2021-10775
- Event Type
- Injury
- Date Received
- April 7, 2021
- Date of Event
- February 9, 2021
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MKJ
- UDI-DI
- 00884838023680
- PMA / PMN Number
- K110825
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
(B)(4) IS A DUPLICATE OF (B)(4). PLEASE REFER TO (B)(4). FOR THE EVALUATION INFORMATION OF THIS DEVICE.
PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
B)(4) IS A DUPLICATE OF (B)(4).
IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS IN USE ON A PATIENT, RESTARTED BEFORE THE SECOND SHOCK COULD BE ADMINISTERED, AND THE TREATMENT WAS DELAYED. THERE WAS NO ADVERSE IMPACT DESPITE THE DELAYED TREATMENT. THE CUSTOMER REPLACED THE DEVICE WITH A DIFFERENT ONE AND CONTINUED TO ADMINISTER TREATMENT.
IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS IN USE ON A PATIENT, RESTARTED BEFORE THE SECOND SHOCK COULD BE ADMINISTERED, AND THE TREATMENT WAS DELAYED. THERE WAS NO ADVERSE IMPACT DESPITE THE DELAYED TREATMENT. THE CUSTOMER REPLACED THE DEVICE WITH A DIFFERENT ONE AND CONTINUED TO ADMINISTER TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523464 | HEARTSTART XL+ DEFIBRILLATOR/MONITOR | DEFIBRILLATOR | MKJ | PHILIPS NORTH AMERICA LLC | 861290 | 00884838023680 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |