FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 1213383
·
Received October 29, 2008
Report
- Report Number
- 2031642-2008-00219
- Event Type
- Malfunction
- Date Received
- October 29, 2008
- Date of Event
- September 30, 2008
- Report Date
- September 30, 2008
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AIR VALVE; AIR FLOW SENSOR.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE VENTILATOR SHUT DOWN AND ALARMED WHILE IN USE ON A PATIENT. REVIEW OF THE VENTILATOR DIAGNOSTIC LOG VERIFIED THE VENTILATOR HAD AN AIR SOURCE ALARM FAULT THAT WAS FOLLOWED BY A VENTILATOR RESTART. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE VENTILATOR HAS TESTED TO OPERATING SPECIFICATIONS. THE SERVICE TECHNICIAN IS REPLACING THE AIR VALVE AND FLOW SENSOR AS A PRECAUTIONARY MEASURE.
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 |