MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-09 for DIAGNOST 56/66/76 70641 NA manufactured by Philips Medizin Systeme.
[1475775]
The collimator was hanging by the detent pin that was stuck on the lip of the collimator bracket. The detent mechanism was bent and damaged. The top cover was lying on the counter.
Patient Sequence No: 1, Text Type: D, B5
[8783407]
The screws were replaced and the collimator was remounted after bending the detent assembly and the off focal vanes back into position. After troubleshooting it was found that a breaker was tripped on the control rack and the pin was damaged on the main connector for the collimator, which was eventually replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768251-2010-00023 |
| MDR Report Key | 1839783 |
| Report Source | 05 |
| Date Received | 2010-09-09 |
| Date of Report | 2009-04-29 |
| Date Mfgr Received | 2009-04-29 |
| Date Added to Maude | 2011-02-10 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DREW QUEEN |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal | 98021 |
| Manufacturer Phone | 4254877199 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAGNOST 56/66/76 |
| Generic Name | IXL (DEVICE, SPOT FILM) |
| Product Code | IXL |
| Date Received | 2010-09-09 |
| Model Number | 70641 |
| Catalog Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDIZIN SYSTEME |
| Manufacturer Address | ROENTGENSTR. 24 HAMBURG 22335 GM 22335 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-09 |