FDA Adverse Event
Injury
Summary report: N
SERVO 900D
MDR report key: 918386
·
Received September 21, 2007
Report
- Report Number
- 8010042-2007-00214
- Event Type
- Injury
- Date Received
- September 21, 2007
- Date of Event
- September 4, 2007
- Report Date
- September 10, 2007
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- CBK
- PMA / PMN Number
- K893786
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
Narratives
Additional Manufacturer Narrative · 1
MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE. MAQUET CRITICAL CARE AB PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Description of Event or Problem · 1
THE CUSTOMER REPORTS THAT WHILE THE PATIENT WAS CONNECTED TO THE VENTILATOR, TWO HEART STOPS OCCURRED. THE MEASURED POST AND EXPIRATORY PRESSURE (PEEP) VALUE WAS 20 CM H2O, ALTHOUGH THE SET PEEP WAS 4 CM H20. ACCORDING TO THE DOCTORS, THE CAUSE OF THE HEART STOPS WERE ATTRIBUTED TO TOO HIGH PEEP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERVO 900D | CBK | MAQUET CRITICAL CARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Life Threatening| R |