MAUDE Adverse Event Report: MAQUET SAS HANAULUX 2004; LIGHT, SURGICAL, CEILING MOUNTED

Device Problem Component Falling (1105)

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

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is being investigated by manufacturing site.

Event Description

On (b)(6) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- hanaulux 2004.As it was stated by customer, the light head fell off next to the patient.There is no injury reported.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by the manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with one of surgical lights- hanaulux 2004 device.It was stated that the safety ring broke and light head fell on the ground next to the patient in the delivery room.It was found that when the event occurred, the surgical light likely did not meet its specification and it contributed to event.In the time when the event occurred the device was being used for the patient treatment.During the investigation it was found that there is no apparent trend with the issue at hand and that the reported scenario has led once to serious injury or worse.It was found that the possible root cause of this event is degradation of the plastic safety sleeve, which after a long period of use, can distort or deteriorate through the use of aggressive cleaning products or disinfectants.Please note that the device was manufactured in 1996, it in use for 22 years until the event occurred.The malfunctioned part ¿ a safety sleeve - should be checked every 6 months during recommended maintenance as described in the chapter ¿inspection by the operator¿ in the user manual for hlx 2000 device 56351039/e.As per incident scenario and the fact that the information about preventive maintenance is not available we can conclude that a device was not well maintained and the manufacturer¿s recommendations were not followed described alike in the user manual and technical notice.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005.Getinge usa sales, llc (b)(4).Contact person: (b)(6).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device (b)(4).Contact person: (b)(6).The issue is still being investigated by manufacturing site.

• Brand Name: HANAULUX 2004
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7548580
• MDR Text Key: 109625369
• Report Number: 9710055-2018-00032
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K895715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 04/30/2018; 04/30/2018; 04/30/2018; 08/23/2018; 09/18/2018
• Supplement Dates FDA Received: 07/03/2018; 07/31/2018; 08/24/2018; 09/18/2018; 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1