MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-11-19 for FOUR MONITOR SUSPENSION 9807-005-01007 NA manufactured by Philips Medical Systems North America.
[17825281]
Pt was being moved from the table when the 4 monitor suspension fell landing on a cart and then fell forward striking the pt and table and then continued to fall to the floor. The pt was struck on the left arm incurring bruising and hematoma at the wrist and mid-forearm. X-ray's were taken and reported as negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1996-00028 |
| MDR Report Key | 51764 |
| Report Source | 05 |
| Date Received | 1996-11-19 |
| Date of Report | 1996-10-29 |
| Date of Event | 1996-10-29 |
| Date Facility Aware | 1996-10-29 |
| Report Date | 1996-10-29 |
| Date Reported to FDA | 1996-11-18 |
| Date Reported to Mfgr | 1996-10-29 |
| Date Mfgr Received | 1996-10-31 |
| Date Added to Maude | 1996-11-29 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOUR MONITOR SUSPENSION |
| Generic Name | MONITOR SUSPENSION |
| Product Code | ITY |
| Date Received | 1996-11-19 |
| Model Number | 9807-005-01007 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 52423 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS NORTH AMERICA |
| Manufacturer Address | 710 BRIDGEPORT AVE. SHELTON CT 06484 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-19 |