FDA Adverse Event
Malfunction
Summary report: N
ESPRIT VENTILATOR
MDR report key: 1213443
·
Received October 29, 2008
Report
- Report Number
- 2031642-2008-00224
- Event Type
- Malfunction
- Date Received
- October 29, 2008
- Date of Event
- October 2, 2008
- Report Date
- October 2, 2008
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K051262
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
STATION SOLENOID
Description of Event or Problem · 1
WHILE SERVICING THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE UNIT FAILED NEONATAL EXTENDED SELF TESTING (EST) DUE TO AN INHALATION PRESSURE TOO LOW. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO PATIENT HARM. THE CUSTOMER DID NOT REPORT AN ISSUE AS NOTED DURING ANY PREVIOUS USAGE. THE SERVICE TECHNICIAN REPORTED THE DURING TESTING THE CIRCUIT PRESSURE WAS DROPPING BELOW SPECIFICATIONS. THE SERVICE TECHNICIAN REPLACED THE 3 STATION SOLENOID TO CORRECT THE FINDING. EXTENDED SELF TESTING (EST) AND PERFORMANCE VERIFICATION TESTING WAS PERFORMED AND ALL TESTING 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 |