MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC MODEL POWER LED CONCEALED LIGHTING SYSTEM; LIGHT, SURGICAL, CEILING MOUNTED

Model Number MODEL POWER LED CONCEALED LIGHTING SYSTEM

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).The reported issue is being investigated.Device not returned to manufacture.

Event Description

It was reported that 1 light sometimes does not work, the other doesn't work at all.No other details provided.Technicians remarks: 4/28/2020 during visual inspection found spring arm not fully seated to the main arm, spring arm was a fall hazard.Retaining clip appears to be bent slightly.Attempted to reinstall the spring arm with new retaining clip, unable to fully seat connection.Inspected the 3 pole receptacle and can see bent connections.Attempted to straighten, unable.4/29/2020 replaced spring arm sn: (b)(4) with sn: (b)(4), attempted to test light-head, no power to light-head.Removed panels and checked for source voltage 120vac.Output is 0vdc.5/5/2020 replaced power board and carrier module.Checked for light head operation.Light-head now functions properly.Performed safety checks.Returned to service.Calibrated tools: fluke 88 multi-meter sn:(b)(4), delta ohm light meter sn: (b)(4), safety analyzer sn: (b)(4).Ref complaint ot # (b)(4).

• Brand Name: MODEL POWER LED CONCEALED LIGHTING SYSTEM
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 10091515
• MDR Text Key: 219345279
• Report Number: 2242352-2020-00447
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL POWER LED CONCEALED LIGHTING SYSTEM
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2020
• 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: N
• Patient Sequence Number: 1