MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-27 for OUTPATIENT II 0224100 OUTPATIENT II DC manufactured by Philips Burton.
[4404970]
Philips (b)(4) received a complaint stating that one of our examination lights (outpatient ii double ceiling light, had detached). It was reported that the head of the exam light involved, detached and grazed the patient. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
[11799943]
Additional serial number: (b)(4). The light was in use when it separated from the joint at the double transition. No injuries occurred and the light was replaced. The unit shows signs of excessive wear, tear and improper maintenance. 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. The light was out of warranty.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009542956-2014-00001 |
| MDR Report Key | 3829335 |
| Report Source | 05 |
| Date Received | 2014-02-27 |
| Date of Report | 2014-02-26 |
| Date of Event | 2014-01-31 |
| Date Mfgr Received | 2014-01-31 |
| Date Added to Maude | 2014-06-12 |
| 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 | TOM LATIONG |
| Manufacturer Street | 11500 MELROSE AVE |
| Manufacturer City | FRANKLIN PARK IL 60131 |
| Manufacturer Country | US |
| Manufacturer Postal | 60131 |
| Manufacturer Phone | 8472888948 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OUTPATIENT II |
| Generic Name | OUTPATIENT II DOUBLE CEILING |
| Product Code | FQP |
| Date Received | 2014-02-27 |
| Returned To Mfg | 2014-02-20 |
| Model Number | 0224100 |
| Catalog Number | OUTPATIENT II DC |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS BURTON |
| Manufacturer Address | 11500 MELROSE AVE FRANKLIN PARK IL 60131 US 60131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-27 |