FDA Adverse Event
Injury
Summary report: N
MODIFIED JACKSON-REES CIRCUIT
MDR report key: 30644
·
Received January 25, 1996
Report
- Report Number
- 30644
- Event Type
- Injury
- Date Received
- January 25, 1996
- Date of Event
- August 16, 1995
- Report Date
- August 23, 1995
- Manufacturer
- KING SYSTEM CORP.
- Product Code
- CAI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THREE MONTH PREMATURE INFANT ADMITTED FOR PYLOROMYOTOMY DUE TO HISTORY OF PYLORIC STENOSIS. DURING INITIAL ANESTHESIA THE CIRCUIT VALVE (POP-OFF OR PRESSURE RELIEF VALVE) MALFUNCTIONED AND WAS UNABLE TO BE CORRECTED. THIS REQUIRED THE INFANT TO REQUIRE IV ANESTHESIA. THE CHILD REQUIRED EXTENDED INTUBATION DUE TO DELAY IN BODY EXCRETING IV AGENTS. INFANT WEIGHT 6-8 1/2 OZ.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODIFIED JACKSON-REES CIRCUIT | ANESTHESIA CIRCUIT | CAI | KING SYSTEM CORP. | 0395B5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | Hospitalization| L| R |