MAUDE Adverse Event Report: MAQUET SAS POWERLED 500; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568350933

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

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 issue with one of surgical lights- powerled.As it was stated by customer, screw with plastic cap fell off into the operating room resulting in necessity to cancel the procedure.Other retaining screws of the spring arms were found to be loose.There was no injury reported however we decided to report the issue based on the potential as any part falling off the surgical light into sterile field or during surgery might be a source of contamination.

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.

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 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).

Event Description

Manufacturer's reference number 192881.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.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).

Event Description

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

Manufacturer Narrative

On 7th january, 2019 maquet sas became aware of an issue with one of surgical lights- powerled.As it was stated by customer, screw with plastic cap fell off into the operating room resulting in necessity to cancel the procedure.Other retaining screws of the spring arms were found to be loose.There was no injury reported however we decided to report the issue based on the potential as any part falling off the surgical light into sterile field or during surgery might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.At the time when the event occurred the device was being used for patient treatment.The root cause is an incorrect tightening of covers side screws during maintenance.The fall of the plastic cap could be a direct result of a loosened screw and a lack of verification during annual maintenance.As there is no information provided who performs preventive maintenance and we have no information if it ever was performed, we can assume that the most likely root cause is lack of maintenance, however it cannot be fully confirmed.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that this is the first complaint 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.

• Brand Name: POWERLED 500
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8266740
• MDR Text Key: 133846503
• Report Number: 9710055-2019-00006
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568350933
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other