MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-05-30 for ULTRANET S 2204643 NA manufactured by Ge Medical Systems S.c.s..
[638477]
It was reported that the collimator fell from the x-ray assembly and was caught by the xr technologist who reported a sprained hand. The concern is that if the event were to recur, serious injury may result.
Patient Sequence No: 1, Text Type: D, B5
[7959751]
The root cause of the event was three of the six screws used to hold the collimator were missing. There is documentation in the service manual instructing the periodic checking of the fasteners holding the collimator. Attempts were made to get the patient information, they were unsuccessful.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611343-2007-00043 |
| MDR Report Key | 857438 |
| Report Source | 05,06 |
| Date Received | 2007-05-30 |
| Date of Report | 2007-05-30 |
| Date of Event | 2007-04-15 |
| Date Mfgr Received | 2007-04-23 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2008-02-04 |
| 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 | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTHA KAMROW |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2623127196 |
| Manufacturer G1 | GE MEDICAL SYSTEMS SCS |
| Manufacturer Street | 283 RUE DE LA MINIERE BP 34 |
| Manufacturer City | BUC CEDEX 7853 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 7853 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRANET S |
| Product Code | IZW |
| Date Received | 2007-05-30 |
| Model Number | 2204643 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | ULTRANET SM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 958152 |
| Manufacturer | GE MEDICAL SYSTEMS S.C.S. |
| Manufacturer Address | 283 RUE DE LA MINIERE BP-34 BUC CEDEX FR 78533 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-30 |