MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-11 for HEWLETT PACKARD 43130A manufactured by Hewlett Packard Company.
[5486]
Patient underwent cabg of the lad artery on 5/26/94. The patient was defibrillated twice with internal paddles and 10 joules following the bypass. The patient jumped during both defibrillations. Mild muscle burns were noted in the heart. The chest was closed and additional surgery (repair of femoral psuedo-aneurysm) was performed. Approximately one hour later, patient sustained v-fib. The chest was re-opened and patient was defibrillated with 30 joules without jumping. The patient was transferred to the icu until 5/28/94 and then to the telemetry unit where he remained as of 6/2/94.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 15583 |
| MDR Report Key | 15583 |
| Date Received | 1994-07-11 |
| Date of Report | 1994-06-03 |
| Date of Event | 1994-05-26 |
| Date Facility Aware | 1994-05-26 |
| Report Date | 1994-06-03 |
| Date Added to Maude | 1994-08-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEWLETT PACKARD |
| Generic Name | DEFIBRILLATOR |
| Product Code | DRK |
| Date Received | 1994-07-11 |
| Model Number | 43130A |
| ID Number | TAG# E15035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8.5 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15575 |
| Manufacturer | HEWLETT PACKARD COMPANY |
| Manufacturer Address | 1700 S. BAKER STREET MCMINNVILLE OR 971289113 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-11 |