FDA Adverse Event
Injury
Summary report: N
ABBOTT
MDR report key: 494828
·
Received November 4, 2003
Report
- Report Number
- MW4003609
- Event Type
- Injury
- Date Received
- November 4, 2003
- Date of Event
- August 27, 2003
- Report Date
- October 27, 2003
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AT APPROX 0325 ON POST-OP DAY 1 NOTED PT ABRUPTLY STOPPED SNORING. FOUND TO BE IN CARDIAC ARREST. CODE CALLED, CPR STARTED WITH ER PHYSICIAN IN ATTENDANCE. EKG RECORDED ASYSTOLE THEN VFIB. DEFIB X2, IV EPHEDRINE, INTUBATED, RESPONSED TO CARDIOVERSION THEN RESUMED ATRIAL FIB. MULTIPLE EEG'S, CT SCANS & NEUROLOGICAL CONSULTS INTERPRETATION OF SEVERE ANOXIC BRAIN INJURY. ON MORPHINE PCA AT TIME OF ARREST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ABBOTT | APM-II PUMP | FRN | ABBOTT LABORATORIES | APM II | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Life Threatening | MORPHINE SULFATE MANUFACTURED BY ABBOTT. |