FDA Adverse Event
Malfunction
Summary report: N
ACHIEVA
MDR report key: 1001846
·
Received February 25, 2008
Report
- Report Number
- 8020893-2008-00069
- Event Type
- Malfunction
- Date Received
- February 25, 2008
- Date of Event
- February 9, 2008
- Report Date
- February 18, 2008
- Manufacturer
- GALWAY (RC)
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
NELLCOR PURITAN BENNETT RECEIVED A REPORT THAT THE VENTILATOR FAILED TO CYCLE WHILE BEING USED ON A PT. THE CUSTOMER STATED: THE SETTING FAILURE ALARM WAS ACTIVATED, NURSE NOTICED THAT THE MACHINE STOPPED OPERATING. WHEN THE DOCTOR REBOOTED THE UNIT, IT FUNCTIONED PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACHIEVA | VENTILATOR | CBK | GALWAY (RC) | ACHIEVA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |