FDA Adverse Event
Death
Summary report: N
MULTIGAS MONITOR
MDR report key: 938448
·
Received November 5, 2007
Report
- Report Number
- 2520313-2007-00022
- Event Type
- Death
- Date Received
- November 5, 2007
- Date of Event
- October 8, 2005
- Report Date
- November 5, 2007
- Manufacturer
- MEDRAD, INC.
- Product Code
- CCK
- PMA / PMN Number
- K983250
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MEDRAD IS IN THE PROCESS OF COMPLETING THE FAILURE ANALYSIS. ONCE THE FAILURE ANALYSIS IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
MEDRAD RECEIVED INFO STATING A PATIENT PASSED AWAY AFTER A PROCEDURE. THE INFORMATION SUGGESTS THE PATIENT DIED DUE TO OXYGEN DEPRIVATION THAT OCCURRED AFTER RECEIVING ANESTHESIA WHILE OBTAINING AN MRI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTIGAS MONITOR | MULTIGAS MONITOR | CCK | MEDRAD, INC. | 9500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |