FDA Adverse Event
Summary report: N
SENSOR MEDICS
MDR report key: 1001874
·
Received January 28, 2008
Report
- Report Number
- 1001874
- Date Received
- January 28, 2008
- Date of Event
- January 8, 2008
- Report Date
- January 28, 2008
- Manufacturer
- CARDINAL HEALTH
- Product Code
- LSZ
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
OSCILLATOR STOPPED WHILE IN USE. RESPIRATORY THERAPIST AND RNS BAGGED PATIENT AND ATTEMPTED TO TROUBLESHOOT EQUIPMENT W/O SUCCESS. DEVICE REMOVED FROM USE. BIOMED DEPT TESTED W/ INITIAL CIRCUIT SETUP; TECH UNABLE TO GET AIRWAY PRESSURE WITH PROVIDED SETUP. REPLACED PT CIRCUIT W/ NEW CIRCUIT. UNIT RAN 12 HRS OVER COURSE OF 2 DAYS W/O PROBLEM, HOLDING CORRECT AIRWAY PRESSURE. 2000HR PM AND CALIBRATION DONE AS PRECAUTION AND DEVICE RETURNED TO SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSOR MEDICS | VENTILATOR, HIGH FREQUENCY OSCILLATOR | LSZ | CARDINAL HEALTH | 3100B | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |