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

Catalog Number ARD568801074

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 maquet sas became aware of an incident with one of surgical lights.As it was stated by customer, the monitor handle fell off during the operation.There is no injury reported.(b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated.Additional information will be provided upon results of investigation.

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 most possible root cause has been established however, it needs to be confirmed.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

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

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).

Event Description

Manufacturer reference number (b)(6).

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 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).Maquet sas became aware of an incident with flat screen holder.As it was stated by the customer, the monitor handle fell off during the operation.Fortunately, there was no adverse outcome reported.It was established that when the event occurred, the flat screen holder did not meet its specification and it contributed to incident.In the time when the event occurred the device was being used for patient treatment.During the investigation it was found that this event is the fourth case reported to getinge regarding detachment of handle support in the last 5 years worldwide.The reported scenario has never led to serious injury or worse.The manufacturer performed an investigation for that case.According to the results of the investigation the en 60601-2-41 standard mentions that the maximum force during the handling must be less than 55 n for a vertical positioning and less than 25 n for a horizontal positioning of the flat screen holder.The pull tests and torsion tests were performed on several handles to verify the resistance of adhesive bonding.The results of these tests show that the adhesive bonding is effective and comply with the en60601-2-41 standard.Moreover, user manual for xs/xd flat screen monitor holders 0421102 ed.2b on page 20 is indicating that the sterilizable handle needs to be checked on a daily inspection.Therefore, we assume that the most probable root cause is mechanical shock, collision or excessive effort applied to the handle.We believe that if the manufacturers recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7586465
• MDR Text Key: 111099603
• Report Number: 9710055-2018-00041
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/31/2019

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
• Device Catalogue Number: ARD568801074
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 05/14/2018; 05/14/2018; 08/24/2018; 09/19/2018; 10/16/2018; 10/16/2018; 10/16/2018; 10/16/2018
• Supplement Dates FDA Received: 07/31/2018; 08/24/2018; 09/19/2018; 10/16/2018; 11/13/2018; 12/07/2018; 01/02/2019; 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1