MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-04-09 for AIMLED SINGLE CEILING ALEDSC manufactured by Philips Burton.
[3342887]
On (b)(6), philips burton rec'd a complaint stating that one of our single ceiling light had detached. It was reported that the unit that had detached had struck a clinician. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10670677]
According to the (b)(4) technician (philips electrical contractor) had made a visit to the site and confirmed that the locking clip was not installed in the unit as indicated in the installation manual, confirming that this case was in fact an installation error, made by the installers, that were either contractors or employees of lancaster general hospital. The complete repair and the report was completed the week of (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009542956-2013-00006 |
| MDR Report Key | 3060874 |
| Report Source | 05 |
| Date Received | 2013-04-09 |
| Date of Report | 2013-04-08 |
| Date of Event | 2013-02-27 |
| Date Mfgr Received | 2013-02-15 |
| Device Manufacturer Date | 2012-10-15 |
| Date Added to Maude | 2013-06-06 |
| 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 MATIONG |
| 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 | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIMLED SINGLE CEILING |
| Generic Name | AIMLED SINGLE CEILING |
| Product Code | FQP |
| Date Received | 2013-04-09 |
| Model Number | ALEDSC |
| Catalog Number | ALEDSC |
| Lot Number | 10/15/12 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-04-09 |