FDA Adverse Event
Other
Summary report: N
MILLENNIUM VENTILATOR
MDR report key: 955752
·
Received April 11, 2007
Report
- Report Number
- 2020676-2007-00005
- Event Type
- Other
- Date Received
- April 11, 2007
- Date of Event
- March 13, 2007
- Report Date
- April 11, 2007
- Manufacturer
- SECHRIST INDUSTRIES, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: ELECTRICAL PROBLEM, CAUSED BY LOOSENED WIRE ON CLIP CONNECTING TO SOLENOID. EVENT DETERMINED TO BE RESULT OF POSSIBLE INCORRECT MAINTAINENCE ACTIONS BY DISTRIBUTOR THAT CAUSED THE WIRE TO BE LOOSENED IN SOCKET. IMPROPERLY SET LOW PRESSURE ALARM (NOT IN ACCORDANCE WITH IFUS) CONTRIBUTED TO LACK OF ALARM DURING EVENT. VENTILATOR TO BE REPAIRED AND RETURNED TO DISTRIBUTOR.
Description of Event or Problem · 1
DISTRIBUTOR REPORTED THAT VENTILATOR PIP WOULD NOT INCREASE AT INSPIRATORY PHASE AND NO VENTILATOR ALARMS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILLENNIUM VENTILATOR | INFANT VENTILATOR | CBK | SECHRIST INDUSTRIES, INC. | MILLENIUM VJ | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |