FDA Adverse Event
Death
Summary report: N
INTERTECH
MDR report key: 132975
·
Received November 17, 1997
Report
- Report Number
- 132975
- Event Type
- Death
- Date Received
- November 17, 1997
- Date of Event
- November 1, 1997
- Report Date
- November 14, 1997
- Manufacturer
- INTERTECH
- Product Code
- BYE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THIS FOLLOW-UP REPORT IS BEING SENT AT THE REQUEST OF THE FDA AND THE MFR. THE ADDITIONAL INFO INCLUDED IN THIS REPORT CONTAINS A COPY OF THE PT'S AUTOPSY REPORT. THE FILING OF THIS REPORT IS TO COMPLY WITH THE SMDA WITH THE INTENT TO IMPROVE THE QUALITY OF THE CARE THAT PT'S RECEIVE. BY FILING THIS REPORT, THE OSU HOSPITALS DOES NOT ADMIT FAULT OR LIABILITY ON BEHALF OF ITS EMPLOYEES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERTECH | PEEP VALVE | BYE | INTERTECH | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Death | AMBU BAG |