FDA Adverse Event
Injury
Summary report: N
SIEMENS
MDR report key: 279290
·
Received May 19, 2000
Report
- Report Number
- MW1018987
- Event Type
- Injury
- Date Received
- May 19, 2000
- Date of Event
- May 15, 2000
- Report Date
- May 17, 2000
- Manufacturer
- SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL DIVISION
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INFANT ON VENTILATOR FOR RESPIRATORY DISTRESS. VENTILATOR DEVELOPED LEAK. PEEP DROPPED. SATS DROPPED FROM 93 TO 89. BABY BAGGED AND VENTILATOR CHANGED. DR REPORTS NO ADVERSE OUTCOME TO BABY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIEMENS | SERVO VENT | CBK | SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL DIVISION | SERVO S-300 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 DAY | Required Intervention |