FDA Adverse Event
Malfunction
Summary report: N
SERVO VENTILATOR 300A
MDR report key: 424885
·
Received October 24, 2002
Report
- Report Number
- 8010042-2002-00281
- Event Type
- Malfunction
- Date Received
- October 24, 2002
- Date of Event
- August 20, 2002
- Report Date
- October 23, 2002
- Manufacturer
- SIEMENS ELEMA AB/LIFE SUPPORT SYSTEMS DIV
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
AN FSE REPORTED RECEIVING A SV300A VENTILATOR INTO THE IR REPAIR FACILITY, THAT HAD REPORTEDLY FAILED TO CYCLE ON A PT. THE FSE WAS UNABLE TO DUPLICATE THE REPORTED FAILURE. THE VENTILATOR WAS RETURNED TO THE CUSTOMER BY THE CUSTOMER'S REQUEST. NO PARTS WERE REMOVED OR REPLACED FROM THE VENTILATOR. NO PARTS WILL BE RETURNED TO SIEMENS MEDICAL SOLUTIONS INC. THERE WERE NO PT INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO VENTILATOR 300A | RESPIRATORY VENTILATOR | CBK | SIEMENS ELEMA AB/LIFE SUPPORT SYSTEMS DIV | 6424704 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention |