MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-09 for ADAC TRANSCAM PN 5200-2338 * manufactured by Philips Medical Systems.
[1290361]
Transcam nuclear medicine camera was being prepped to be used. During prep, the tech said the detector suddenly came forward towards him and fell to the floor. Three of the right bolts holding the detector to the yoke were bent, bolts appears to have pulled through threads in the detector. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1641320 |
| MDR Report Key | 1641320 |
| Date Received | 2010-03-09 |
| Date of Report | 2010-03-09 |
| Date of Event | 2010-02-05 |
| Report Date | 2010-03-09 |
| Date Reported to FDA | 2010-03-09 |
| Date Added to Maude | 2010-03-26 |
| 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 | ADAC TRANSCAM |
| Generic Name | NUCLEAR MEDICINE, GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2010-03-09 |
| Model Number | PN 5200-2338 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 14 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 595 MINER RD. CLEVELAND OH 44143 US 44143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-09 |