FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 2537182
·
Received April 16, 2012
Report
- Report Number
- 2031642-2012-00178
- Event Type
- Malfunction
- Date Received
- April 16, 2012
- Date of Event
- March 29, 2012
- Report Date
- March 29, 2012
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K981072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
AFTER PERFORMING PREVENTIVE MAINTENANCE SERVICE, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE BACKUP ALARM FAILED. THE SERVICE TECHNICIAN REPLACED THE MMI PCB BOARD TO CORRECT THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED PER OPERATING SPECIFICATIONS. THE CUSTOMER DID NOT REPORT THE FINDING DURING ANY PREVIOUS USAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.
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 |