MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-31 for ABD/HEAD HOLDER FOR CT 8129629 manufactured by Siemens Medical Systems, Inc..
[21072108]
Abdomen/head holder in ct fell off table while pt still on table. Pt had hands under head so head did not drop. No injury. Holder locking mechanism did not hold.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006592 |
| MDR Report Key | 23926 |
| Date Received | 1995-07-31 |
| Date of Report | 1995-05-12 |
| Date of Event | 1995-04-27 |
| Date Added to Maude | 1995-08-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABD/HEAD HOLDER FOR CT |
| Generic Name | ABDOMEN AND HEAD HOLDER |
| Product Code | IWY |
| Date Received | 1995-07-31 |
| Model Number | 8129629 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24260 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | ISELIN NJ 088300401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-07-31 |