MAUDE Adverse Event Report: MAQUET SAS MEDIUM PENDANT 1200-900 MODUTEC; TUBING, PRESSURE AND ACCESSORIES

Catalog Number ARD517025999

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

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

Event Date 05/21/2017

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided after investigation result.

Event Description

On (b)(6) maquet (b)(4) became aware of an incident with the medium pendant device.It was stated that the end cap of the device was loose and fell off.No information about the circumstances and possible patient involvement were provided.The issue is being investigated.Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas received customer complaint related to (b)(4) ceiling unit where it was stated that the end cap fell down.The investigation was performed on the issue.Per information provided in the service report it has been found that the nurse hit the end cup with the light.According to user manual for (b)(4) maquet recommends yearly maintenance or more frequently (if required by regulations in force in each country) to the hospital technical department trained by maquet.The same user manual include steps and parts which need to be checked during the maintenance and according to the list e.G.Beam cover needs to be visually and manually checked if it is tightened and also appearance of the device needs to be visually checked.It also includes a list of warning such as warning related to rotation of the beams and accessories which needs to be taken carefully to avoid collision with personnel or with other equipment.Based on information at hand the root cause of the failure could be established as user error as the issue was caused by the hitting of the end cap by the lighthead.As it was established the device which played a role in the investigated herein issue was not up to its specification and contributed to the outcomes of the event.No information about any injury has been provided, however we decided to report this case in abundance of caution.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: MEDIUM PENDANT 1200-900 MODUTEC
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• Manufacturer (Section G): FREDERIC LELEU - MAQUET SAS; parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; FR 45074
• Manufacturer Contact: parc de limère; avenue de la pomme de pi; orléans cedex 2 45074 ; 0332382587
• MDR Report Key: 6643082
• MDR Text Key: 77829292
• Report Number: 9710055-2017-00042
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD517025999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1