FDA Adverse Event
Malfunction
Summary report: N
HEARTSTART MRX
MDR report key: 2933162
·
Received January 4, 2013
Report
- Report Number
- 2933162
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- June 10, 2010
- Report Date
- June 17, 2010
- Manufacturer
- PHILLIPS MEDICAL SYSTEMS
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- User Facility report
Narratives
Description of Event or Problem · 1
NO READING ON CAPNOGRAPHY; FAILED TO RECOGNIZE END TIDAL CO2.======================HEALTH PROFESSIONAL'S IMPRESSION.======================PARAMEDIC UNSURE WHAT CAUSED THE PROBLEM. MONITOR REMOVED FROM SERVICE AND EVALUATED BY CLINICAL ENGINEERING. NO PROBLEM IDENTIFIED AND MONITOR RETURNED TO USE. THE FILTER WAS NOT SAVED. THE POSSIBLE ISSUES INCLUDE THE FILTER,THE CONNECTION NOT COMPLETELY SEEDED BY PARAMEDIC OR PROBLEM WITH MONITOR. PATIENT INFORMATION NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5713 | HEARTSTART MRX | AUTOMATED EXTERNAL DEFIBRILLATORS | MKJ | PHILLIPS MEDICAL SYSTEMS | HEARTSTART MRX | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |