FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 1030666
·
Received April 15, 2008
Report
- Report Number
- 2031642-2008-00090
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 17, 2008
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN AND ALARMED WHILE IN USE ON A PT. THERE WAS NO PT HARM REPORTED. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN LOG HISTORY INDICATING A RESTART OF THE VENTILATOR OCCURRED. THE SERVICE TECHNICIAN TESTED THE EXTERNAL BATTERY AND REPORTED IT WAS BELOW SPECIFICATIONS. THE SERVICE TECHNICIAN REPLACED THE EXTERNAL BATTERY TO CORRECT THE PROBLEM. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND THE VENTILATOR PASSED PER OPERATING SPECIFICATIONS.
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 | UNK |