MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2000

Model Number HLX20051XLCONFORT

Device Problems Component Falling (1105); Degraded (1153)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

While at customer site, maquet sales representative was informed that a plastic cover detached from one of the surgical lights in operating room #2, prior to a surgical procedure.There was no patient in the room at the time of the event and no injuries were reported to maquet.(b)(4).

Manufacturer Narrative

A maquet representative went to the site to collect additional information concerning the reported event.The representative found the customer was using adhesive tape to secure the covers to the surgical light.The customer alleges that they did this because the screws that hold the covers come off after some time when the light is moved around.It appeared to the maquet representative that the lights had been handled roughly, causing damage to the fastening table.The customer has elected not to have maquet service repair this discontinued device.They have ordered replacement covers and will be installing the covers themselves.The yearly maintenance program in the hanaulux 2000 series operating manual includes a verification of the plastic parts by a specialized technician every six months.Maquet is not the primary service provider of this light.Maquet medical systems usa submits this report on behalf of the device manufacturing facility.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: HANAULUX 2000
• Manufacturer (Section D): MAQUET SAS; orleans ; FR
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon, orleans cedex 2 4507 4; FR 45074
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3979216
• MDR Text Key: 4635715
• Report Number: 9710055-2014-00040
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/02/2014,05/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLX20051XLCONFORT
• Other Device ID Number: 56077629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/02/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2014
• Date Manufacturer Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2003
• 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