FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX -EMS DEFIBRILLATOR
MDR report key: 2200886
·
Received June 30, 2011
Report
- Report Number
- 1218950-2011-01878
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Report Date
- June 3, 2011
- Manufacturer
- PHILIPS HEALTHCARE - ANDOVER
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER REPORTED THAT THE 5 AND 12 LEAD ECG READINGS WERE INACCURATE. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND COULD NOT DUPLICATE THE ISSUE. THE ECG TRUNK CABLE WAS REPLACED AT THE DISCRETION OF REPAIR PERSONNEL. WE WILL CONSIDER THIS A FAILURE BASED ON THE CUSTOMER'S REPORTED SYMPTOM ONLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 5 AND 12 LEAD ECG READINGS WERE INACCURATE.
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 |