MAUDE Adverse Event Report: BERCHTOLD CORP EXAMINATION LIGHT F 300, CEILING MOUNT, LED DIMMABLE, DOUBLE-ARM, 24V DC, 100-

Catalog Number CE 2863075

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the f300 light would not power on.The light was visually inspected by a stryker field service technician who reported a small separation at the upper suspension arm.A stryker quality engineer initiated a review of the manufacturing history.The evaluation is ongoing and a supplemental will be submitted upon completion.There was no patient involvement, no injury and no adverse consequence reported.

Event Description

It was reported that the f300 light would not power on.There was no patient involvement, no injury and no adverse consequence reported.

Manufacturer Narrative

It was reported that the f300 exam light would not power on.When stryker field service technician (sfst) visited the site, he noted that the snap ring had slipped and was no longer making connection with the upper suspension arm electrical connection.He re-seated the snap ring into the slot and inspected for correct seating.This resolved the issue and the light could be powered on.The light did not fall and there was not visible separation in the unit.There were no adverse consequences or patient involvement.This exam light was installed in march 2015.There are no records of service by stryker following installation.The f300 operating manual (57363 rev h) outlines that general maintenance should be performed by berchtold (stryker) annually.It was confirmed by the sfst that all equipment in this facility is serviced by an in-house biomed department.It is believed that someone at the site improperly serviced the equipment.If the snap ring was mis-seated at installation, it is likely that the site would have seen a failure sooner than 16 months after installation.The snap ring was properly seated by the sfst and the issue was resolved.

Event Description

It was reported that the f300 light would not power on.There was no patient involvement, no injury and no adverse consequence reported.

• Brand Name: EXAMINATION LIGHT F 300, CEILING MOUNT, LED DIMMABLE, DOUBLE-ARM, 24V DC, 100-
• Type of Device: EXAMINATION LIGHT
• Manufacturer (Section D): BERCHTOLD CORP; 1950 hanahan road; charleston SC 29406
• Manufacturer (Section G): BERCHTOLD CORP; 1950 hanahan road; charleston SC 29406
• Manufacturer Contact: adam gorzeman ; 1950 hanahan road; charleston, SC 29406 ; 8435696100
• MDR Report Key: 5873101
• MDR Text Key: 52085688
• Report Number: 0001220865-2016-00019
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CE 2863075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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