FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2241506
·
Received August 9, 2011
Report
- Report Number
- 1218950-2011-02312
- Event Type
- Malfunction
- Date Received
- August 9, 2011
- Report Date
- July 19, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS CUSTOMER REPORTED A FAILURE TO DISCHARGE VIA EXTERNAL PADDLES. THERE WAS NO NEGATIVE IMPACT TO THE INVOLVED PT. THE EQUIPMENT WAS EVALUATED LOCALLY BY PHILIPS. THE REPORTED SYMPTOM WAS REPRODUCED. REPLACEMENT OF THE EXTERNAL PADDLE SET RESOLVED THE SYMPTOM.
Description of Event or Problem · 1
THIS CUSTOMER REPORTED A FAILURE TO DISCHARGE VIA EXTERNAL PADDLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEARTSTART MRX | MKJ | PHILIPS HEALTHCARE - ANDOVER | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |