MAUDE Adverse Event Report: MAQUET SAS LUCEA 40; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD568601998

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2018 maquet (b)(4) became aware of an issue with one of lights- lucea 40.As it was stated, two of three screws located on the light head came off.There was no injury reported, however we decided to report the issue in abundance of caution as any part falling off into sterile field or during procedure might be a source of contamination.(b)(4).

Manufacturer Narrative

The date provided in 'event date' within the initial report was incorrect.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 correction was made as the incorrect product code was initially provided.Correct product code is kzf.The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(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 45 barbour pond drive wayne, nj 07470.Contact person: (b)(6).The reference number in a1 and b5 field was incorrect, the correct number is (b)(6) instead of (b)(6).With the complaint at hand, we received an information that two of three screws located on the light head were noticed to be missing.It is unknown under what circumstances the situation took place.The purpose of affected screws is to maintain the cover of the light head to the main structure.The device involved in the event is lucea 40.Serial number of the device is (b)(4) and defective part number is ard568601998.Manufacturing date is 28th february, 2013.The investigation into the root cause of the problem occurrence has been performed and concludes that the cause of the screws detachment is lack of maintenance on the customer¿s site.From information gathered, we established that the device in under company¿s service agreement, therefore as an action we are to perform a retraining for the service technician to remind about requirements indicated by the manufacturer, namely tightening information available in the lucea 40 | technical manual | 01712en04 |( assembly of the screws using torque wrench calibrated at 0.9 nm).In summary and based on the information available to date, when the event occurred, the device was not being used for the patient treatment but it did play a role in the reported event.Performed evaluation of the involved device allowed to establish that it failed to meet the manufacturer specification.Although no injury occurred as a result of this event it was decided to report it to the competent authorities based on the potential and in abundance of caution.Given the circumstances and the fact that the issue is found to be single and isolated event getinge does not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: LUCEA 40
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8271774
• MDR Text Key: 134371194
• Report Number: 9710055-2019-00020
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• PMA/PMN Number: K113679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/17/2019

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: ARD568601998
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 12/14/2018; 12/14/2018; 12/14/2018; 12/14/2018
• Supplement Dates FDA Received: 02/15/2019; 03/12/2019; 04/09/2019; 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other