MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-05-10 for BUCKEY DIAGNOST CS4 9890-010-06522 NA manufactured by Philips Medical Systems.
[15253287]
Trauma diagnost was brought into lateral position by radiation technician. After positioning stand and setting up for exposure, trauma diagnost cassette-tube arm rotational latch assembly released without activation causing cassette arm to rotate onto bedside and then patient. Patient was struck in the abdomen area. There was no evidence that the patient was injured by the arm striking them. However, since the patient had many injuries from their accident it was not totally possible to detect any new injuries from the arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-2002-00006 |
| MDR Report Key | 394327 |
| Report Source | 05,06 |
| Date Received | 2002-05-10 |
| Date of Report | 2002-04-13 |
| Date of Event | 2002-04-13 |
| Report Date | 2002-04-13 |
| Date Mfgr Received | 2002-04-13 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2002-05-16 |
| 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 | DREW QUEEN |
| Manufacturer Street | 22100 BOTHELL, EVERETT HWY. |
| Manufacturer City | BOTHELL WA 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4254877199 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUCKEY DIAGNOST CS4 |
| Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Product Code | IYB |
| Date Received | 2002-05-10 |
| Model Number | 9890-010-06522 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 383334 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Baseline Brand Name | TRAUMA DIAGNOST II |
| Baseline Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT (CS4) |
| Baseline Model No | 9890-010-06522 |
| Baseline Catalog No | NA |
| Baseline Device Family | CEILING SUSPENSION |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K945278 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-10 |