MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-03-04 for DOUBLE MONITOR SUSPENSION 46-240485P4/45296130 NA manufactured by Ge Medical Sys.
[21249579]
It was reported to co that the monitor detached from the suspension and fell to the floor. Apparently the mounting bolt loosened allowing the monitor to fall. The monitor was re-attached and the bolt torqued to specification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-1997-00009 |
| MDR Report Key | 75244 |
| Report Source | 07 |
| Date Received | 1997-03-04 |
| Date of Report | 1997-03-04 |
| Date of Event | 1997-02-05 |
| Date Mfgr Received | 1997-02-05 |
| Device Manufacturer Date | 1992-11-01 |
| Date Added to Maude | 1997-03-13 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLE MONITOR SUSPENSION |
| Generic Name | DIAGNOSTIC X-RAY |
| Product Code | ITY |
| Date Received | 1997-03-04 |
| Model Number | 46-240485P4/45296130 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 75021 |
| Manufacturer | GE MEDICAL SYS |
| Manufacturer Address | 3000 NORTH GRANDVIEW BLVD. WAUKESHA WI 53188 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-04 |