MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-01 for SCOP SPOT FILM DEVICE TYPE #9848-500-09901 NA manufactured by Philips Co.
[65237]
During an upper gi film, as the radiology table was being lowered from an erect to flat position, the carriage started to slowly slip downward until it was resting on the pt's chest. Radiologist and technician tried forcing the carriage up enough for the pt to move out from underneath. They were not able to move the carriage but the pt was able to slide out due to his small size.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 105068 |
| MDR Report Key | 105068 |
| Date Received | 1997-07-01 |
| Date of Report | 1997-03-06 |
| Date of Event | 1997-03-05 |
| Date Facility Aware | 1997-03-05 |
| Report Date | 1997-03-06 |
| Date Reported to Mfgr | 1997-03-07 |
| Date Added to Maude | 1997-07-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOP SPOT FILM DEVICE |
| Generic Name | NA |
| Product Code | IXL |
| Date Received | 1997-07-01 |
| Model Number | TYPE #9848-500-09901 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | PART# 4512-130-32051 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 103318 |
| Manufacturer | PHILIPS CO |
| Manufacturer Address | 10008 INTERNATIONAL BLVD. CINCINNATI OH 45246 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-01 |