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 76 70639 NA manufactured by Philips Medizin Systeme.
[15207516]
The cover which prevented the collimator from falling had missing screws.
Patient Sequence No: 1, Text Type: D, B5
[15658576]
The cover screws were reinstalled and the collimator operated according to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768251-2010-00024 |
| MDR Report Key | 1839773 |
| Report Source | 05 |
| Date Received | 2010-09-09 |
| Date of Report | 2009-07-20 |
| Date Mfgr Received | 2009-07-20 |
| Date Added to Maude | 2011-01-25 |
| 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 76 |
| Generic Name | IXL (DEVICE, SPOT FILM) |
| Product Code | IXL |
| Date Received | 2010-09-09 |
| Model Number | 70639 |
| 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 |