FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 3820144
·
Received April 3, 2014
Report
- Report Number
- 2031642-2014-00230
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Report Date
- March 11, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR AC POWER CORD HAD THERMAL DAMAGE AT THE PLUG. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE ON A PT THEREFORE, THERE WAS NO PT INVOLVEMENT OR HARM. THE MFR'S FIELD SERVICE ENGINEER VERIFIED THAT THE PLUG WAS BADLY BURNED AT THE WALL RECEPTACLE END. THE DAMAGE AS NOTED, MAY RESULT IN A LOSS OF AC POWER TO THE VENTILATOR DURING OPERATION. IF THE VENTILATOR SHUTS DOWN, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE. THE SERVICE ENGINEER REPLACED THE POWER CORD TO COMPLETE THE REPAIR. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201771 | ESPRIT VENTILATOR | VENTILATOR, CONTINUOUS | CBK | RESPIRONICS CALIFORNIA, INC. | V1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |