FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX -EMS DEFIBRILLATOR
MDR report key: 2121262
·
Received May 4, 2011
Report
- Report Number
- 1218950-2011-01272
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Report Date
- April 14, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS CUSTOMER REPORTED THAT DURING A CARDIAC ARREST, THE DEVICE FAILED TO CHARGE VIA PADS IN THE MANUAL MODE. THERE WAS NO NEGATIVE PATIENT IMPACT. THE CUSTOMER EVALUATED THE DEVICE AND IDENTIFIED AN INCOMPLETE ELECTRICAL CONNECTION BETWEEN THE THERAPY CABLE AND THERAPY PORT. REPLACEMENT OF THE PORT AND CABLE RESOLVED THE SYMPTOM. WE ARE UNABLE TO DETERMINE WHICH PART FAILED AS MORE THAN ONE PART WAS REPLACED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A CARDIAC ARREST, THE DEVICE FAILED TO CHARGE VIA PADS IN THE MANUAL MODE. THERE WAS NO NEGATIVE PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX -EMS DEFIBRILLATOR | MKJ | PHILIPS HEALTHCARE | M3536A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |