FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 2853532
·
Received December 3, 2012
Report
- Report Number
- 2031642-2012-00520
- Event Type
- Malfunction
- Date Received
- December 3, 2012
- Report Date
- November 16, 2012
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER TO PERFORM SERVICE H3 OTHER TEXT : CUSTOMER TO PERFORM SERVICE
Additional Manufacturer Narrative · 1
CORRECTED DATA: UNIT WAS NOT IN USE ON A PATIENT.
Description of Event or Problem · 1
THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PATIENT WHEN THE VENT INOP OCCURRED ON STARTUP, THEREFORE THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER REPORTED THE BLOWER WAS REPLACED TO ADDRESS THE REPORTED PROBLEM.
Description of Event or Problem · 1
THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE CUSTOMER REPORTED THE POWER SUPPLY WOULD BE REPLACED TO ADDRESS THE REPORTED PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESPRIT VENTILATOR | VENTILATOR, CONTINUOUS | CBK | RESPIRONICS CALIFORNIA, INC. | V1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |