MAUDE Adverse Event Report: MAQUET SAS HLED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number 515076999

Device Problems Grounding Malfunction (1271); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 27th january, 2021 getinge became aware of an issue with hled surgical light.According to technician findings there was lack of grounding on the device, moreover, reviewing the photographic evidence the paint chipping occurred, additionally one of labels was torn with missing particles.There was no injury reported, however, we decided to report the issue based on the potential of electrical shock for operator of the device and paint chipping and torn label with missing particles are creating risk for the patient, as any particles falling into sterile field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer's reference number: (b)(4).

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with hled surgical light.According to getinge technician findings there was lack of grounding on the device, moreover, reviewing the photographic evidence the paint chipping occurred, additionally one of labels was torn with missing particles.There was no injury reported, however, we decided to report the issue based on the potential of electrical shock for operator of the device and paint chipping and torn label with missing particles are creating risk, as any particles falling into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as there was lack of grounding on the device, the paint was chipping and label was torn which contributed to the reportable situation.There is no information if the device was or was not being used for the patient treatment at the time.After reviewing the information provided for the customer product complaints investigated here, (b)(4).The lack of earth connections observed for some installed pwd/hled configurations is clearly a non compliance with all recommendations and warnings mentioned in our installation manuals (susp sa ri enes 0132602, ed.2a).For future installations we recommend to carefully follow the instructions provided (susp sa ri enes 0132602, ed.2a).The most probable root cause of these paintwork damages is the collision between other products such as the spring arm or lighthead.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The user manual (40515-hled_userman_01601, ed.09, page 25-26) includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.About the torn label the most probable root cause is an excessive friction during cleaning or inappropriate cleaning products.We believe that if the manufacturer recommendation would have been followed the reported situation would have been avoided.

• Brand Name: HLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11271221
• MDR Text Key: 247565234
• Report Number: 9710055-2021-00038
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2021

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: No Information
• Device Model Number: 515076999
• Device Catalogue Number: 515076999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/08/2021; 09/30/2021
• Supplement Dates FDA Received: 02/25/2021; 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1