FDA Adverse Event
Malfunction
Summary report: N
PASSPORT 2 MONITOR
MDR report key: 3091849
·
Received April 30, 2013
Report
- Report Number
- 2221819-2013-00963
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- April 11, 2013
- Report Date
- April 30, 2013
- Manufacturer
- MINDRAY DS USA, INC.
- Product Code
- MHX
- PMA / PMN Number
- 020550
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
MINDRAY SERVICE REP EVALUATED THE UNIT, BUT WAS UNABLE TO REPRODUCE ANY PROBLEMS; FOUND SPO2 SENSOR FAILURE. UNIT WAS SAFETY TESTED TO FACTORY SPECIFICATIONS.
Description of Event or Problem · 1
CUSTOMER REPORTED AN ISSUE WITH THE PASSPORT 2 MONITOR, WHICH MAY HAVE RESULTED IN A LOSS OF SPO2 AND ECG MONITORING. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 187606 | PASSPORT 2 MONITOR | PATIENT MONITOR | MHX | MINDRAY DS USA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |