MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-04-23 for APEX SP-4 NUCLEAR SYSTEM NA manufactured by Elgems, Ltd..
[173697]
It was reported to gems that the operator failed to tighten the plate to the detector when replacing the collimator. The collimator and plate fell off when the detector was rotated over the pt. It touched the pt, but there was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9613299-1999-00002 |
| MDR Report Key | 221165 |
| Report Source | 00 |
| Date Received | 1999-04-23 |
| Date of Report | 1999-04-22 |
| Date of Event | 1999-03-11 |
| Date Mfgr Received | 1999-03-11 |
| Date Added to Maude | 1999-05-03 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APEX SP-4 NUCLEAR SYSTEM |
| Generic Name | NUCLEAR MEDICINE |
| Product Code | IYY |
| Date Received | 1999-04-23 |
| Model Number | SP-4 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 416445SP4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 214470 |
| Manufacturer | ELGEMS, LTD. |
| Manufacturer Address | ADVANCED TECHNOLOGY CTR HAIFA IS 31004 |
| Baseline Brand Name | APEX SP-4 NUCLEAR SYSTEM |
| Baseline Generic Name | NUCLEAR MEDICINE |
| Baseline Model No | SP-4 |
| Baseline Catalog No | NA |
| Baseline ID | 416445SP4 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-04-23 |