MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2000-02-15 for KODAK X-MATIC ID CAMERA 2 8261703 manufactured by Eastman Kodak Co..
[152728]
Two technologists received shocks from a newly installed camera. The camera and electrical outlet was subsequently tested by an electrician. The electrician indicated that the technologist was shocked with 108 volts. The electrician believed the device was not grounded. The second electrician consulted a cardiologist. No damage was noted by an ekg eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1315356-2000-00001 |
| MDR Report Key | 263276 |
| Report Source | 06,08 |
| Date Received | 2000-02-15 |
| Date of Report | 2000-02-14 |
| Date of Event | 2000-01-17 |
| Date Mfgr Received | 2000-01-28 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2000-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | JUDITH WALLACE/MANAGER |
| Manufacturer Street | 343 STATE ST. |
| Manufacturer City | ROCHESTER NY 146501131 |
| Manufacturer Country | US |
| Manufacturer Postal | 146501131 |
| Manufacturer Phone | 7167246111 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK X-MATIC ID CAMERA |
| Generic Name | PATIENT ID CAMERA |
| Product Code | IZJ |
| Date Received | 2000-02-15 |
| Returned To Mfg | 2000-02-02 |
| Model Number | 2 |
| Catalog Number | 8261703 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 254872 |
| Manufacturer | EASTMAN KODAK CO. |
| Manufacturer Address | 901 ELMGROVE RD. ROCHESTER NY 14650 US |
| Baseline Brand Name | KODAK X-MATIC ID CAMERA |
| Baseline Generic Name | PATIENT ID CAMERA |
| Baseline Model No | 2 |
| Baseline Catalog No | 8261703 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2000-02-15 |