FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
MDR report key: 6352888
·
Received February 23, 2017
Report
- Report Number
- 1218950-2017-01265
- Event Type
- Malfunction
- Date Received
- February 23, 2017
- Report Date
- January 30, 2017
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K110825
- Removal / Correction Number
- Z-2328-2015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Additional Manufacturer Narrative · 1
(B)(4) INCLUDES UPGRADING THE DEVICE SOFTWARE AND REPLACING THE FOLLOWING PARTS: SPEAKER ASSEMBLY, BATTERY PCA WITH STABILIZER, THERAPY PCA, PROCESSOR PCA, REAR ASSEMBLY, THERAPY PORT RECEPTACLE WITH THERAPY PORT RECEPTACLE EXTENDER, LAN TO PROCESSOR PCA CABLE, POWER SUPPLY TO THERAPY PCA CABLE, AND ECG PORT CONNECTOR BLOCK.
Description of Event or Problem · 1
IT WAS REPORTED TO PHILIPS THE DEVICE FAILED THE THERAPY DELIVERY TEST. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137195 | HEARTSTART XL+ DEFIBRILLATOR/MONITOR | ALS DEFIBRILLATOR MONITOR | MKJ | PHILIPS MEDICAL SYSTEMS | 861290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |