MAUDE Adverse Event Report: PHILIPS BURTON; AIM MEDICAL LIGHTS

Model Number ALEDSC

Device Problems Detachment Of Device Component (1104); Crack (1135); Material Torqued (2980)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

Customer reported that aim light head became detached.The stop had been over-torqued and safety locking key cracked the collar.No injuries reported.It was found that there are seven (7) complaints related to the cracked collars that resulted in the light head detached from the spring arm.No injuries reported among the seven complaints.Upon examination, it was discovered that the plastic collars used to secure the spring arm were cracking due to over-torqued during installation which resulted in the light head to separate from the spring arm.In order to prevent this issue from happening, philips burton is replacing all plastic collars with new aluminum collars in the field.Field action decision was taken to proceed with the field correction.

Event Description

Customer reported that aim light head became detached.The stop had been over-torqued and safety locking key cracked the collar.No injuries reported.It was found that there are seven (7) complaints related to the cracked collars that resulted in the light head detached from the spring arm.No injuries reported among the seven complaints.Upon examination, it was discovered that the plastic collars used to secure the spring arm were cracking due to over-torqued during installation which resulted in the light head to separate from the spring arm.

• Type of Device: AIM MEDICAL LIGHTS
• Manufacturer (Section D): PHILIPS BURTON; 11500 melrose ave; franklin park IL 60131
• Manufacturer (Section G): PHILIPS BURTON; 11500 melrose ave; franklin park IL 60131
• Manufacturer Contact: khalid nijmeh ; 11500 melrose ave; franklin park, IL 60131 ; 8472888905
• MDR Report Key: 6114183
• MDR Text Key: 60692063
• Report Number: 3009542956-2016-00005
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ALEDSC
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1