MAUDE Adverse Event Report: MAQUET (SUZHOU) CO.,LTD. ALPHAPORT; TUBING, PRESSURE AND ACCESSORIES

Lot Number 8101501419

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

Maquet suzhou went through the following records to verify if there was any deficiency relevant the beam end cover prior to this complaint.- maquet suzhou reviewed the design of the end cover, and mechanical evaluation testing has been performed according to iec 60601-1.The design of the end cover was demonstrated robust and no issue was found.- maquet suzhou reviewed the dhr for the involved pendant, no abnormality was found relevant to the arm and its end cover during the production and inspection.- the complaint history record has been reviewed and no feedback was received relevant to the involved pendant during installation or use.Per above information on hand, there was no deficiency relevant the beam end cover prior to this complaint.We are waiting for the investigation result on customer's side by maquet fse.A follow-up report will be submitted when additional information becomes available.

Event Description

On (b)(6) 2019 getinge became aware of an issue with alphaport device.As it was stated, the cover of fluid delivery arm fell into operating field.There was no injury reported however we decided to report the issue based on the potential as any parts falling off into sterile field or during procedure might cause a contamination.

Event Description

On 16th october, 2019 getinge became aware of an issue with alphaport device.As it was stated, the cover of fluid delivery arm fell into operating field.There was no injury reported however we decided to report the issue based on the potential as any parts falling off into sterile field or during procedure might cause a contamination.

Manufacturer Narrative

When received this complaint, maquet suzhou went through dhr record, complaint history record and design review of concerned alpha-port pendant to verify there was no deficiency identified from production or field feedback relevant the arm cover prior to this complaint.Maquet field service engineer visited the hospital as planned, it's clarified with the hospital staff that the beam end cover fell off after being hit by the surgical light in the same room, rather than a normal use.This event occurred during handling the surgical light, the light arm struck the end cover of alpha-port which caused the cover dislodged and dropped.No one was hit and no any injury was involved.The warning message "care should be taken when rotating the beams, to avoid collisions with personnel or with other equipment" is included in the instruction for use, but it seems not fully followed in this case.From the above on-site investigation, it could be concluded the root cause is the collision between surgical light and alpha-port due to the negligence during operation , which put the abnormal external force to the end cover then made it off.Remedial action (the remedial action was completed before (b)(6) 2019.) maquet field service engineer checked the cover and found it's in a normal condition, so it's fixed back to the arm by adding a silicone seal to ensure a stronger joint.Corrective action : hospital promised to proceed with the installation of a silicone seal joint to all alpha-port beams in the other rooms to avoid the similar issue.

• Brand Name: ALPHAPORT
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou
• MDR Report Key: 9259392
• MDR Text Key: 196298283
• Report Number: 3007417753-2019-00002
• 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: consumer,health professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 8101501419
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1