FDA Adverse Event
Malfunction
Summary report: N
V200 VENTILATOR
MDR report key: 1843122
·
Received September 23, 2010
Report
- Report Number
- 2031642-2010-00265
- Event Type
- Malfunction
- Date Received
- September 23, 2010
- Date of Event
- August 26, 2010
- Report Date
- August 26, 2010
- 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
Additional Manufacturer Narrative · 1
ALARM.
Description of Event or Problem · 1
WHILE PERFORMING PRE-OPERATIONAL TESTING OF THE VENTILATOR PRIOR TO PREVENTIVE MAINTENANCE SERVICE, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE BACKUP ALARM TEST FAILED. THE SERVICE TECHNICIAN REPLACED THE BACKUP ALARM TO CORRECT THE FINDING. EXTENDED SELF TESTING AND PERFORMANCE VERIFICATION 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 | V200 VENTILATOR | VENTILATOR, CONTINUOUS | CBK | RESPIRONICS CALIFORNIA, INC. | V200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |