MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-26 for AIM LED DOUBLE CEILING ALEDDC manufactured by Philips Burton.
[4169596]
On (b)(4) 2013, philips burton received a complaint stating that one of our double ceiling aim led light heads, had detached from the extension arm. It was reported that the head of the exam light involved, detached from the extension arm and struck a patient in the hand. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
[11492685]
(b)(4). (repair) documents a (b)(4) technician (philips electrical contractor) had made a visit to the site and discovered that the locking clip was not installed in the unit as referenced in the installation manual. This confirmed an installation error, made by the installers, that were either contractors or employees of (b)(6) hospital medical center. The (b)(4) contractors report ((b)(4)) to philips, stated that the light head separated from the unit because the locking clip was not installed. The device was reinstalled with the safety clip in place and the collar rotated to ensure that the clip does not come off the device. Pictures the mera technician had taken verifies that this was correctly performed. The report of this repair was submitted to philips on (b)(4) 2013.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009542956-2013-00008 |
| MDR Report Key | 3599116 |
| Report Source | 05 |
| Date Received | 2013-11-26 |
| Date of Report | 2013-11-22 |
| Date Mfgr Received | 2013-11-04 |
| Device Manufacturer Date | 2013-02-25 |
| Date Added to Maude | 2014-03-05 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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 | AIM LED DOUBLE CEILING |
| Generic Name | AIM LED DOUBLE CEILING |
| Product Code | FQP |
| Date Received | 2013-11-26 |
| Model Number | ALEDDC |
| Catalog Number | ALEDDC |
| Lot Number | CREATE DATE: 02/25/2013 |
| ID Number | ISSUE DATE: 03/20/2013 |
| Operator | OTHER |
| 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 | 2013-11-26 |