MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-05-20 for OUTPATIENT II OPII NA manufactured by Burton Medical Products.
[881607]
Light fell at extension arm junction during procedure. No injuries occurred.
Patient Sequence No: 1, Text Type: D, B5
[7885187]
The light was in use when it separated from the down tube at the extension arm junction. No injuries occurred and the light was replaced. The unit shows signs of excessive wear and tear. The arm was continually fatigued by the end-user pushing the extension arm up into the pivot support. This caused the extension arm to separate and drop. The end-suer should have noticed the damage occurring at the junction and had the light repaired prior to the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2018492-2007-00026 |
| MDR Report Key | 1077323 |
| Report Source | 06 |
| Date Received | 2008-05-20 |
| Date of Report | 2007-11-19 |
| Date of Event | 2007-10-25 |
| Date Mfgr Received | 2007-10-25 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2010-04-01 |
| 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 | CHELSEA MITCHELL |
| Manufacturer Street | 21100 LASSEN ST. |
| Manufacturer City | CHATSWORTH CA 91311 |
| Manufacturer Country | US |
| Manufacturer Postal | 91311 |
| Manufacturer Phone | 8187018700 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUTPATIENT II |
| Generic Name | DIAGNOSTIC LIGHT |
| Product Code | FCQ |
| Date Received | 2008-05-20 |
| Model Number | OPII |
| 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 | BURTON MEDICAL PRODUCTS |
| Manufacturer Address | CHATSWORTH CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-20 |