MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-03-30 for ARRITECHNO CINE CAMERA 9896-010-04831 NA manufactured by Philips Medical Systems.
[96718]
Allegedly, during a cardiac catheterization, the technologist was moving a lead shield and he accidently struck the film magazine causing it to detach from the cine camera and fall and hit the pt on the abdomen. No injuries or impact to the pt were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1998-00009 |
| MDR Report Key | 160806 |
| Report Source | 06 |
| Date Received | 1998-03-30 |
| Date of Report | 1998-03-06 |
| Date of Event | 1998-03-06 |
| Date Facility Aware | 1998-03-06 |
| Report Date | 1998-03-06 |
| Date Reported to Mfgr | 1998-03-06 |
| Date Mfgr Received | 1998-03-06 |
| Date Added to Maude | 1998-04-07 |
| 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 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARRITECHNO CINE CAMERA |
| Generic Name | 35MM CINE CAMERA |
| Product Code | IZJ |
| Date Received | 1998-03-30 |
| Model Number | 9896-010-04831 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 156598 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | PO BOX 10.000, VEENPLUIS 4-6 BEST NL 5680 DA |
| Baseline Brand Name | ARRITECHNO CAMERA RM90 W/O LENS |
| Baseline Generic Name | CINE CAMERA |
| Baseline Model No | 9896-010-04831 |
| 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 | 1998-03-30 |