FDA Adverse Event
Malfunction
Summary report: N
PLV 100
MDR report key: 2575668
·
Received May 2, 2012
Report
- Report Number
- 2518422-2012-00594
- Event Type
- Malfunction
- Date Received
- May 2, 2012
- Date of Event
- April 5, 2012
- Report Date
- April 5, 2012
- Manufacturer
- RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
- Product Code
- CBK
- PMA / PMN Number
- K832467
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE VENTILATOR WAS RETURNED TO THE MFR FOR EVAL AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE¿S POWER SWITCH WAS REPLACED TO ADDRESS THE ISSUE.
Description of Event or Problem · 1
THE MFR RECEIVED INFO ALLEGING THE VENTILATOR FAILS TO ALARM AT TIMES, THERE WAS NO PT HARM OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLV 100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | 35001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |