MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-14 for EXCEL manufactured by *.
[307191]
Physical therapist reported patient experienced a "shock" as therapist was administering an ultrasound treatment to patient's left anterior shoulder.
Patient Sequence No: 1, Text Type: D, B5
[316088]
Add'l info received from mfr 2/3/03: model number: 3000. Catalog number: part number 0998-00-0077-15. Lot number: na. The customer reported that while the unit was in use on a pt during a pulmonary angiogram, the unit's display blacked out several times. They were unable to run pulmonary reading recorder strips. The pt was switched to another unit and therapy was continued. No pt injury was reported. Datascope was not advised of the event until four months after it had occurred. At that time, follow-up phone calls to the ge clinical services biomeds who typically maintain the monitor, and risk mgmt (also the medwatch contact person), determined that the site had elected to retire the monitor from use, based upon its age. It was ten years old at the time of the event. The deivce has been retired from use by the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 432686 |
| MDR Report Key | 432686 |
| Date Received | 2002-12-14 |
| Date of Report | 2002-09-20 |
| Date of Event | 2002-09-20 |
| Date Facility Aware | 2002-09-20 |
| Report Date | 2002-09-20 |
| Date Added to Maude | 2002-12-17 |
| 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 | PATIENT |
| 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 | EXCEL |
| Generic Name | ULTRAMAX SX |
| Product Code | LPQ |
| Date Received | 2002-12-14 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 421647 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-12-14 |