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

Model Number BLUE30

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.(b)(4).(b)(6).

Event Description

On (b)(6) 2018 (b)(4) became aware of an incident with one of surgical lights blue 30.As it was stated, the glass cracked on the device during surgical procedure.There is no injury reported however we decided to report the issue in abundance of caution as any part falling during surgery or into sterile field might be a source of contamination.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

(b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturers reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

The issue is being investigated by manufacturing site.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an incident with one of the blue 30 surgical lights.As it was stated, the underside cover cracked on the device during surgical procedure.There is no injury reported however we decided to report the issue in abundance of caution as any part falling during surgery or into sterile field might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification.At the time when the event occurred the device was being used for the patient treatment.During the investigation, it was found that the reported scenario is a single and isolated case for this model type.The event was caused by misuse of the device by the customer.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

Manufacturer's 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 45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).The issue is still being investigated by manufacturing site.

Event Description

Manufacturer's reference number (b)(4).

Event Description

Manufacturer's reference number 2018- 61685.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

• Brand Name: BLUE
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8186816
• MDR Text Key: 131380651
• Report Number: 9710055-2018-00200
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/18/2019

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 Model Number: BLUE30
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 11/28/2018; 12/11/2019
• Supplement Dates FDA Received: 01/17/2019; 02/07/2019; 03/05/2019; 03/29/2019; 04/18/2019; 05/14/2019; 06/05/2019; 06/28/2019; 07/23/2019; 08/19/2019; 09/13/2019; 10/08/2019; 10/31/2019; 11/22/2019; 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other