MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-01 for CLINIXE SYSTEM 70438 manufactured by Philips Medical Systems (cleveland), Inc..
[17977734]
The customer states the wall bucky tray is able to be pulled out. The field service engineer (fse) went to the site and confirmed that the screws that retain the catch component of the wall bucky system were sheared off. This resulted in the bucky tray being able to be pulled out of the bucky system by the user. The wall bucky system screws were replaced and secured with loctite. The bucky tray can no longer be pulled entirely out of the wall bucky system. There was no report of death or serious injury.
Patient Sequence No: 1, Text Type: D, B5
[18174395]
Note: we have not completed our investigation of this event. We will file a f/u mdr at the completion of the investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525965-2012-00044 |
| MDR Report Key | 2685274 |
| Report Source | 06 |
| Date Received | 2012-08-01 |
| Date of Report | 2012-05-11 |
| Date Mfgr Received | 2012-05-11 |
| Date Added to Maude | 2012-11-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KUMUDINI CARTER |
| Manufacturer Street | 595 MINER RD. |
| Manufacturer City | CLEVELAND OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404833032 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINIXE SYSTEM |
| Product Code | IZF |
| Date Received | 2012-08-01 |
| Model Number | 70438 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
| Manufacturer Address | 595 MINER RD. CLEVELAND OH 44143 US 44143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-01 |