FDA Adverse Event
Injury
Summary report: N
1933149-1997-00005
MDR report key: 132542
·
Received November 12, 1997
Report
- Report Number
- 1933149-1997-00005
- Event Type
- Injury
- Date Received
- November 12, 1997
- Date of Event
- October 15, 1997
- Manufacturer
- PURITAN-BENNETT CORP/SLEEP THERAPEUTICS DIVISION
- Product Code
- BZA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE PT WAS SETUP ON A RESPIRATORY SUPPORT DEVICE WITH 8 LITERS OF OXYGEN BEING BLED IN THROUGH THE OXYGEN ADAPTER. THE ADAPTER WAS CONNECTED TO THE OUTLET FILTER OF THE RESPIRATORY SUPPORT DEVICE. IT WAS REPORTED THAT A THERAPIST ENTERING THE ROOM TO GIVE A BREATHING TREATMENT NOTICED THE 02 FLOWMETER INDICATED ZERO FLOW. THE THERAPIST TOOK A PULSE OXIMETRY READING WHICH SHOWED THE PT'S SATURATION AT 54. THE PT WAS PLACED ON A VENTURI MASK AND THE SATURATION LEVELS RECOVERED WITHOUT INJURY TO THE PT. THE HOSPITAL REPORTED FINDING THE OXYGEN ADAPTER PUSHED ON TO THE OUTLET FILTER TO THE POINT OF OCCLUDING THE OXYGEN PORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BZA | PURITAN-BENNETT CORP/SLEEP THERAPEUTICS DIVISION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |