FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
MDR report key: 4781574
·
Received May 19, 2015
Report
- Report Number
- 1218950-2015-02711
- Event Type
- Malfunction
- Date Received
- May 19, 2015
- Report Date
- April 28, 2015
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K110825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART XL+ DEFIBRILLATOR POWER INDICATION WAS NOT SHOWING DURING OPCHECK. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325094 | HEARTSTART XL+ DEFIBRILLATOR/MONITOR | ALS DEFIBRILLATOR MONITOR | MKJ | PHILIPS MEDICAL SYSTEMS | 861290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |