MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-16 for ARRITECHNO CINE CAMERA 9896-010-04721 NA manufactured by Philips Medical Systems.
[107343]
Allegedly, the film magazine detached from the cine camera and fell and hit the pt. No injuries or impact to the pt were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1998-00008 |
| MDR Report Key | 158007 |
| Report Source | 05,06 |
| Date Received | 1998-03-16 |
| Date of Report | 1998-02-14 |
| Date of Event | 1998-02-14 |
| Date Facility Aware | 1998-02-14 |
| Report Date | 1998-02-14 |
| Date Reported to Mfgr | 1998-02-14 |
| Date Mfgr Received | 1998-02-14 |
| Date Added to Maude | 1998-03-23 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARRITECHNO CINE CAMERA |
| Generic Name | 35MM CINE CAMERA |
| Product Code | IZJ |
| Date Received | 1998-03-16 |
| Model Number | 9896-010-04721 |
| 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 | 153941 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | * BEST NL |
| Baseline Brand Name | ARRITECHNO CINE CAMERA |
| Baseline Generic Name | CINE CAMERA |
| Baseline Model No | 9896-010-04721 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | 35 MM CINE CAMERA |
| 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 | 1. Other | 1998-03-16 |