FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 3131576
·
Received May 17, 2013
Report
- Report Number
- 1218950-2013-01864
- Event Type
- Malfunction
- Date Received
- May 17, 2013
- Report Date
- April 25, 2013
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE CUSTOMER REQUESTED CALIBRATION AFTER IT WAS REPORTED THAT THE ETCO2 VALUES IN TESTING WERE DISCREPANT FROM THE VALUES OF OTHER DEVICES. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219990 | HEARTSTART MRX | MKJ | PHILIPS MEDICAL SYSTEMS | M3535A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |