MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-08-06 for SCOPO 53 9804-315-51007 NA manufactured by Philips Medical Systems.
[15489553]
A patient was being examined on this x-ray system. The spot film device which was held above the patient suddenly lost tension due to a cable failure. The spot film device began to free fall downward. It just came into contact with the face side of the patient before coming to a stop. The patient was laying on their back and flat on the x-ray table. No physical injuries were observed and no medical treatment was performed on the patient. However, the patient complained of abdominal and substernal pains after incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-2003-00012 |
| MDR Report Key | 478091 |
| Report Source | 05 |
| Date Received | 2003-08-06 |
| Date of Report | 2003-07-07 |
| Date of Event | 2003-07-07 |
| Report Date | 2003-07-07 |
| Date Reported to FDA | 2003-08-06 |
| Date Mfgr Received | 2003-07-08 |
| Device Manufacturer Date | 1985-12-01 |
| Date Added to Maude | 2003-08-19 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DREW QUEEN |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4254877199 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | ROENTGENSTRASSE 24 HAMBURG |
| Manufacturer City | * 2000 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOPO 53 |
| Generic Name | SPOT FILM DEVICE |
| Product Code | IXL |
| Date Received | 2003-08-06 |
| Model Number | 9804-315-51007 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 18 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 466899 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG * GM 2000 |
| Baseline Brand Name | SCOPO 53 |
| Baseline Generic Name | SPOT FILM DEVICE |
| Baseline Model No | 9804-315-51007 |
| Baseline Catalog No | NA |
| Baseline Device Family | DIAGNOST 72 |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-08-06 |