MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-05-02 for 1055MM CAMERA 9807-500-40001 NA manufactured by Philips Medical Systems.
[16288748]
Reportedly, the pt was lying on the table and the technologist lifted the image intensfier (ii) assembly with one hand on the ii and one hand on the underside of the 105mm cine camera. As the technologist was raising the ii assembly, the 105mm camera detached and began to fall towards the pt. The technologist was able to partially deflect the camera but the pt was struck a glancing blow on the forehead. The pt initially complained of a headache and a c-collar was placed on his neck. Subsequent x-rays of the pt were negative and reported info at this time indicates that the pt was not seriously injuried.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-2000-00008 |
| MDR Report Key | 278056 |
| Report Source | 05,06 |
| Date Received | 2000-05-02 |
| Date of Report | 2000-04-14 |
| Date of Event | 2000-04-14 |
| Date Facility Aware | 2000-04-14 |
| Report Date | 2000-04-14 |
| Date Reported to Mfgr | 2000-04-14 |
| Date Mfgr Received | 2000-04-14 |
| Date Added to Maude | 2000-05-19 |
| 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 | 3 |
| Manufacturer Contact | FRANK GIANELLI |
| Manufacturer Street | 710 BRIDGEPORT AVE PO BOX 860 |
| Manufacturer City | SHELTON CT 064840917 |
| Manufacturer Country | US |
| Manufacturer Postal | 064840917 |
| Manufacturer Phone | 2039267729 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1055MM CAMERA |
| Generic Name | CINE CAMERA |
| Product Code | IXJ |
| Date Received | 2000-05-02 |
| Model Number | 9807-500-40001 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 269143 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | PO BOX 10.000 VEENPLUIS 4-6 BEST NL 5680 DA |
| Baseline Brand Name | 105MM CAMERA |
| Baseline Generic Name | CINE CAMERA |
| Baseline Model No | 9807-500-40001 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | 105 MM CINE CAMERAS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-05-02 |