FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX - EMS DEFIBRILLATOR
MDR report key: 2250986
·
Received August 31, 2011
Report
- Report Number
- 1218950-2011-02570
- Event Type
- Malfunction
- Date Received
- August 31, 2011
- Report Date
- August 3, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DID NOT SWITCH (POWER) ON. THERE WAS NO REPORT OF PT INVOLVEMENT. PHILIPS FSE EVALUATED THE DEVICE AND CONFIRMED THE COMPLAINT. THE POWER AND THERAPY PCA WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TEST AND WAS PUT BACK IN SERVICE. SINCE MULTIPLE ASSEMBLIES WERE REPLACED WE WERE UNABLE TO DETERMINE WHICH PART CAUSED THE FAILURE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE DID NOT SWITCH (POWER) ON. THERE WAS NO REPORT OF PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX - EMS DEFIBRILLATOR | MKJ | PHILIPS HEALTHCARE - ANDOVER | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |