MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-09-20 for CS 2/4 CEILING SUSPENSION 9890-010-06521 NA manufactured by Philips Medezin Systeme.
[232667]
The cover of the ceiling crane (cs4) fell off, striking a patient on the leg. The patient did not complain of great pain. The hospital informed the family member. The ceiling crane cover had a split several inches long and it is not determined if the split occurred before or after the cover fell. The locks on the cover secured the cover 100% on the right side and 75% on the left. Nothing else abnormal was noted. The patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-2001-00015 |
| MDR Report Key | 353060 |
| Report Source | 06 |
| Date Received | 2001-09-20 |
| Date of Report | 2001-09-19 |
| Date of Event | 2001-08-20 |
| Date Facility Aware | 2001-08-20 |
| Report Date | 2001-09-19 |
| Date Reported to FDA | 2001-09-12 |
| Date Mfgr Received | 2001-08-28 |
| Date Added to Maude | 2001-09-26 |
| 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 | SARAH BAXTER |
| Manufacturer Street | 472 WHEELERS FARMS ROAD P.O. BOX 3828 |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | 4877665 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CS 2/4 CEILING SUSPENSION |
| Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Product Code | IYB |
| Date Received | 2001-09-20 |
| Model Number | 9890-010-06521 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 342315 |
| Manufacturer | PHILIPS MEDEZIN SYSTEME |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG GM 2000 |
| Baseline Brand Name | CS 2/4 |
| Baseline Generic Name | DIAGNOSTIC X-RAY TUBE MOUNT |
| Baseline Model No | 9890-010-06521 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | BUCKY DIAGNOST CS 2/4 FAMILY |
| 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 | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-09-20 |