MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-30 for * manufactured by *.
[300635]
Rptr rec'd a call from someone at a hospital regarding a "clicking" noise in their hand/foot unit. The description of the noise sounded just like what is common with the ferrite pot course of the ballast or they snap together when power is applied and a magnetic field is created. The caller wanted to know if there could be any chance of a dangerous situation with a potential shock hazard to either the pt or the operator. Reporter assured caller that the machine was thoroughly grounded and that any such risk was very low, but if they had any concerns they should have it checked before further use. They were to have their biomedical people check the machine before further use and call back if they felt there was anything requiring further attention. No call was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1029278 |
| MDR Report Key | 477898 |
| Date Received | 2003-07-30 |
| Date Added to Maude | 2003-08-19 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | KGL |
| Date Received | 2003-07-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 466706 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-30 |