FDA Adverse Event
Death
Summary report: N
VOLUME VENTILATOR / MRI COMPATIBLE
MDR report key: 231112
·
Received July 8, 1999
Report
- Report Number
- 231112
- Event Type
- Death
- Date Received
- July 8, 1999
- Date of Event
- June 22, 1999
- Report Date
- July 6, 1999
- Manufacturer
- MONAGHAN MEDICAL CORP.
- Product Code
- IKN
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
LEUKEMIA PT ON VENT OT MRI. AT THE END OF PROCEDURE, PT STILL ON VENT, THE MEDICAL RESIDENT NOTED A DECREASED HEART RATE. THE PT WAS CODED AND RETURNED TO NURSING UNIT. PT WAS CODED AGAIN ON NURSING UNIT AND EXPIRED. AT THE CONCLUSION OF THE FIRST CODE IT WAS DETERMINED THAT THE FIRST OXYGEN TANK WAS EMPTY AND THE SECOND TANK WAS NOT TURNED ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOLUME VENTILATOR / MRI COMPATIBLE | VENTILATOR | IKN | MONAGHAN MEDICAL CORP. | 225/SIMV | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Death |