MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-19 for BEE HIVE DTM 1064 manufactured by Telefactor Corp..
[18164175]
Patient experienced a burning sensation when leads of an eeg machine were plugged in. The procedure was stopped and the incident investigated. The equipment was tested by biomedical engineers and found to be defective. Equipment was then returned to manufacturer for additional testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 25773 |
| MDR Report Key | 25773 |
| Date Received | 1995-01-19 |
| Date of Report | 1994-08-01 |
| Date of Event | 1994-07-27 |
| Date Facility Aware | 1994-07-27 |
| Report Date | 1994-08-01 |
| Date Added to Maude | 1995-09-20 |
| 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 | BEE HIVE |
| Generic Name | DIGITAL TELEMETRY MULTIPLEXER |
| Product Code | GYA |
| Date Received | 1995-01-19 |
| Returned To Mfg | 1994-07-28 |
| Model Number | DTM 1064 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 26374 |
| Manufacturer | TELEFACTOR CORP. |
| Manufacturer Address | 1094 NEW HAVEN AVE. WEST CONSHAKEN PA 19428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-01-19 |