FDA Adverse Event
Other
Summary report: N
UNK
MDR report key: 307069
·
Received November 29, 2000
Report
- Report Number
- 1825511-2000-00030
- Event Type
- Other
- Date Received
- November 29, 2000
- Date of Event
- July 28, 2000
- Report Date
- November 29, 2000
- Manufacturer
- PURITAN-BENNETT CRYOGENIC EQUIPMENT DIVISION
- Product Code
- BYJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE HOMECARE PROVIDERS INSURANCE CARRIER REPORTED THE FOLLOWING INFORMATION: (1) THE CLAIMANT WAS RECEIVING LIQUID OXYGEN PRESCRIBED AT 6LPM FROM 2 RESERVOIRS. (2) THE CLAIMANT'S FAMILY MEMBER CLAIMS THE RESERVOIRS STOPPED DELIVERING OXYGEN AND THE CLAIMANT ALLEGEDY HAD A 'SEIZURE' AS A RESULT.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FOR EVAL ONN 10/2001. THE DEVICE WAS MANUFACTURED BY CAIRE AND WAS NOT MANUFACTURE BY PURITAN-BENNETT. THE DEVICE WAS RETURNED TO THE HOMECARE PROVIDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | UNK | BYJ | PURITAN-BENNETT CRYOGENIC EQUIPMENT DIVISION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |