MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-01 for SPOT PHOTOTHERAPY FLOOR MOUNT LIGHT 6600-0287-901 manufactured by Burton Medical Products Corp..
[34933458]
End user states possible cause of 360 degree rotation as pivot support pin shearing.
Patient Sequence No: 1, Text Type: N, H10
[34933459]
End user reported that light rotated past pivot stop resulting in light tipping over. Light reported to have fallen and hitting an incubator. Lights were reported as being able to rotate 360 degrees.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2018492-2004-00017 |
| MDR Report Key | 5327263 |
| Date Received | 2004-09-01 |
| Date of Report | 2004-08-25 |
| Date of Event | 2004-08-11 |
| Date Mfgr Received | 2004-08-13 |
| Date Added to Maude | 2015-12-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | WAYNE OKAZAKI |
| Manufacturer Street | 21100 LASSEN ST. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8187018700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SPOT PHOTOTHERAPY FLOOR MOUNT LIGHT |
| Generic Name | FLOORMOUNT |
| Product Code | FCQ |
| Date Received | 2004-09-01 |
| Model Number | 6600-0287-901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BURTON MEDICAL PRODUCTS CORP. |
| Manufacturer Address | 21100 LASSEN ST. CHATSWORTH CA 91311 US 91311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-01 |