MAUDE Adverse Event Report: PHILIPS BURTON OP PLUS, MEDICAL EXAMINATION LIGHT; OPL PLUS 0102540

Model Number 0102540

Device Problems Break (1069); Environmental Compatibility Problem (2929)

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

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

Philips burton received a customer's complaint regarding op plus light broke off on (b)(6) 2016.During a procedure the medical assistant was moving the light, it broke off at the first swivel section, and then fell down.Consequently the light did not impact any person, and there were no injuries.Capa has been opened in philips burton quality system to document the incident and assure accurate and timely submitting of mdrs.Note: the light was manufactured in 1995 and is well beyond its warranty period and usable life.Device is over 20 years old.

Event Description

On (b)(4) 2016 philips burton received a complaint from (b)(6) regarding op plus light broke off.The complaint state's: "we had an incident on (b)(6) with a ceiling mounted burton outpatient ii light.In the middle of a procedure, the light broke off.Fortunately, the patient was only shaken and not hurt.It could have shut down the room, but we had a day full of procedures, so we had to improvise.Since we could not move the procedure chair, we cut the lamp wires and removed the dangling light.In its place, we used a portable light (one of yours too).I have attached photos of the break.The metal literally tore apart.Granted these lights are old and out of warranty, but is this normal? the broken light is model 0102540, serial number (b)(4).".

• Brand Name: OP PLUS, MEDICAL EXAMINATION LIGHT
• Type of Device: OPL PLUS 0102540
• Manufacturer (Section D): PHILIPS BURTON; 11500 melrose ave; franklin park IL 84728 8890
• 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: 5588105
• MDR Text Key: 44041291
• Report Number: 3009542956-2016-00002
• 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: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Assistant
• Device Model Number: 0102540
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Device Age: 21 YR
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR