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

Catalog Number ARD567910901

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 01/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue will be investigated by manufacturing site.

Event Description

On (b)(6) 2018 maquet (b)(4) became aware of an incident related to surgical light.The spring arm has torn on the weld and hang on the cables.There was no patient involvement as the issue occurred before a use on the patient.We still do not have a confirmation which device was involved in the event, but the most probable device is hanaulux 2000.We will send a follow-up report if the issue will be related to other product.(b)(4).

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 maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074 exemption # e2018005.Getinge usa sales, llc (b)(6).A customer complaint registered with internal number (b)(4) was received, it concerns the breakage of a surgical light spring arm.The arm came down unexpectedly but not during an actual surgical procedure.The device failed to meet specifications, it was not being used for treatment or diagnosis, and it caused the reported event.Our investigation shows that the spring arm in question was part of our field action with fda reference number (b)(4).This field action was launched to remedy a design deficiency of the spring arm that could result in potential cracks on the pivot point and further in the breakage on the edge of the welding joint of the acrobat 2000 spring arms manufactured between 2000 and 2006.The unit in this complaint was found to have failed due to the issue remedied by this z-0182-2010 action.This is possible because as our investigation shows the spring arm was not replaced as was required by the field action.This in turn occurred since the customer was supplied with a list of serial numbers that was incomplete for their location.Therefore they did not report the involved product back to the company for it to be repaired.Also the issue was not detected during maintenance since maintenance is carried out by a third party, not maquet.We have found the root cause to be: an incidental mishap where it was omitted to present the customer with the full list of devices in their possession, compounded by the fact maintenance is not performed by maquet which would have been a second chance to capture this omission.As a result of our findings we have performed the correction of changing the broken spring arm, as well as having made sure there are no other involved devices at this customer location.The parts are replaced now; the parts were send to the customer with shipment number (b)(4).The medical technician at the customer, mr.(b)(6) at (b)(6) replaced the parts.We do not believe this issue corresponds with earlier issues.The case here appears unrelated in that it was caused by a unique set of coinciding circumstances.We still believe the field action was overall effective and the issue is down to a legacy database issue with only incidental impact.

• Brand Name: HANAULUX
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7237009
• MDR Text Key: 99102317
• Report Number: 9710055-2018-00006
• 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
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD567910901
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1