MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-10-25 for DIAGNOST 76 70641 NA manufactured by Philips Medical Systems.
[19931691]
The collimator box appeared to be loose. The field service engineer found loose screws holding the collimator ring on the tube.
Patient Sequence No: 1, Text Type: D, B5
[20100060]
On (b)(4), 2010 a philips service engineer examined the system and found the screws holding the collimator ring on the x ray tube to be loose. The engineer properly tightened the collimator per system specification and verified operation and alignment. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003768251-2010-00041 |
| MDR Report Key | 1898908 |
| Report Source | 05,07 |
| Date Received | 2010-10-25 |
| Date of Report | 2010-09-29 |
| Date of Event | 2010-09-29 |
| Date Mfgr Received | 2010-09-29 |
| Date Added to Maude | 2011-02-11 |
| 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 98041 |
| Manufacturer Country | US |
| Manufacturer Postal | 98041 |
| Manufacturer Phone | 4254877199 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | ROENTGENSTRASSE 24 |
| Manufacturer City | HAMBURG 22335 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 22335 |
| Single Use | 3 |
| 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 | 2010-10-25 |
| Model Number | 70641 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | ROENTGENSTRASSE 24 HAMBURG 22335 GM 22335 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-25 |