MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-01 for HP ECHOTRANSDUCER 1000 NA manufactured by Hewlett Packard.
[68185]
Outpatient was to undergo echocardiogram. As transducer touched pt's chest, she indicated that she felt a shock, lasting only a few seconds. No burn was evident. Machine was taken out of service. Transducer found to have a nick/small crack down the middle of the head. Head replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 107692 |
| MDR Report Key | 107692 |
| Date Received | 1997-07-01 |
| Date of Report | 1997-03-21 |
| Date of Event | 1997-03-11 |
| Date Facility Aware | 1997-03-21 |
| Report Date | 1997-04-06 |
| Date Reported to Mfgr | 1997-03-14 |
| Date Added to Maude | 1997-07-28 |
| 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 |
| 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 | HP ECHOTRANSDUCER |
| Generic Name | ECHOTRANSDUCER |
| Product Code | DXK |
| Date Received | 1997-07-01 |
| Model Number | 1000 |
| Catalog Number | NA |
| Lot Number | NONE |
| ID Number | NONE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 105846 |
| Manufacturer | HEWLETT PACKARD |
| Manufacturer Address | 10535 HARWIN DRIVE HOUSTON TX 77036 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-01 |