FDA Adverse Event
Malfunction
Summary report: N
PLV-100
MDR report key: 3231896
·
Received July 15, 2013
Report
- Report Number
- 2518422-2013-01402
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- May 24, 2011
- Report Date
- May 24, 2011
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CBK
- PMA / PMN Number
- K832467
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DURING THE EVAL OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ISSUE RELATED TO THE PISTON CYLINDER WAS OBSERVED. THE DEVICE'S PISTON CYLINDER WAS REPLACED TO ADDRESS THE ISSUE. THIS REPORT IS BEING SUBMITTED AS PART OF A PROGRAM TO RETROSPECTIVELY REVIEW POSSIBLE DEVICE MALFUNCTIONS THAT DID NOT INVOLVE ANY INJURY, TO DETERMINE WHETHER THEY ARE REPORTABLE UNDER 21 CFR PART 803 AND THE MANUFACTURER'S UPDATED REPORTING PROCEDURES. THIS PROGRAM IS BEING UNDERTAKEN TO ADDRESS FDA WARNING LETTER (B)(4).
Description of Event or Problem · 1
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326784 | PLV-100 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | RESPIRONICS INC. | 35001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |