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

Model Number ARD567232241C

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Other text : device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an situation when axle boltsin the ceiling tubes which snapped off were found.No information about harm of patient or operator was provided, however based we decided to report this issue based on potential as complained situation could led to falling of the device which might led to serious injury.

Event Description

Manufacturer's reference number: 277710.

Manufacturer Narrative

The issue is being investigated by the manufacturing site.

Event Description

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

Manufacturer Narrative

The issue is still being investigated.Additional information will be provided upon results of investigation.

Event Description

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

Manufacturer Narrative

Getinge became aware of information that suggests axle bolts that are normally located in the ceiling tubes of the prismalix device, were found snapped off.No information about harm of patient or operator was provided, however based we decided to report this issue based on potential as complained situation could lead to falling of the device which might lead to serious injury.The analysis of the screws shows a rupture zone located in the same threading zone: 12 mm under the screw head.The fractures are perpendicular to the axis of the screws.The threads in engagement do not appear deformed.There is a presence of metal residues between the threads.These are the evidences reported by the laboratory who performed the technical study.They brought the conclusion that the rupture is due to a mechanical fatigue over time.The operating manual mentions the required maintenance and inspection to be performed by a certified technician per the prismalix preventive maintenance program ¿the 4 maintenance keys¿, mentions to check that the suspension is firmly attached by manually manipulating the configuration and then to check the tightening of fixation screws on the suspension tube.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Given the circumstances and the fact that the occurrence rate is considered to be low we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

• Brand Name: PRISMALIX
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9508555
• MDR Text Key: 179257516
• Report Number: 9710055-2019-00367
• 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
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567232241C
• Device Catalogue Number: ARD567232241C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1