MAUDE Adverse Event Report: MAQUET SAS HANAULUX 3000; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD566705999

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of an incident with one of the surgical lights- hanaulux 3000.As it was stated by the customer, the light head of the device fell down in the operating room during the processing of the room by the operation team.The issue resulted in a shoulder injury of the nurse, however so far we did not receive any information if it required medical intervention.Moreover, the ceiling of the operating room was also damaged as the remaining part of the spring arm hit it.(b)(4).

Manufacturer Narrative

It appeared that the device involved in this issue is included in the scope of field safety corrective action (b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

On (b)(6) 2019 maquet sas became aware of an incident with one of the surgical lights- hanaulux 3000.As it was stated by the customer, the light head of the device fell down in the operating room during the processing of the room by the operation team.The issue resulted in a shoulder injury of the nurse, however so far we did not receive any information if it required medical intervention.It was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification.During the event occurrence, the device was being used for patient treatment.During this investigation it was established that the reported issue has resulted in a serious injury or worse.The breakage appeared due to the tearing of the spring arm tube on the edge of the welding joint.The spring arm used in the device is of production year 2005.The spring arm design was adapted by increasing the thickness of the tube from 2006 production onwards.The old version of the tube has 1,35 mm of thickness, whereas the new version of tube has 2,35 mm.As a result, the external diameter of tube has increased to 34 mm.We have addressed this issue with a previous field action msa-2009-003-iu[z-0182/188-2010] and since we see recurrence of the events - as we received new complaints from certain markets where these devices are still in use- we started field action msa-2017-002-iu in those markets.The device involved in this event is affected by this field action.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, (b)(4).Exemption # e2018005.(b)(4).

• Brand Name: HANAULUX 3000
• 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: 8460203
• MDR Text Key: 140450651
• Report Number: 9710055-2019-00103
• 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,distri
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD566705999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other