MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-10 for METTLER SONICATOR ME 730 NA manufactured by Mettler Electronics.
[19545221]
Pt was evaluated for lower back pain. An ultrasound treatment was indicated and provided on her lower back at 1. 5 w/cm2. After about one minute into the treatment an audible crackle was heard and the pt jumped and complained of a shocking sensation. The treatment was discontinued and the machine was sequestered. The therapy was continued with another machine without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 110639 |
| MDR Report Key | 110639 |
| Date Received | 1997-07-10 |
| Date of Report | 1997-06-23 |
| Date of Event | 1997-06-13 |
| Date Facility Aware | 1997-06-13 |
| Report Date | 1997-06-23 |
| Date Reported to Mfgr | 1997-06-23 |
| Date Added to Maude | 1997-08-06 |
| 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 | PHYSICAL THERAPIST |
| 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 | METTLER SONICATOR |
| Generic Name | THERAPEUTIC ULTRASOUND |
| Product Code | IMI |
| Date Received | 1997-07-10 |
| Model Number | ME 730 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | B42537 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 22 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 108658 |
| Manufacturer | METTLER ELECTRONICS |
| Manufacturer Address | 1333 S CLAUDINA ST ANAHEIM CA 92805 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-10 |