MAUDE Adverse Event Report: HELENA LU MAQUET; TUBING, PRESSURE AND ACCESSORIES

Model Number MODUEVO(ENERGY)

Device Problems Material Puncture/Hole (1504); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet (b)(4) conducted following initial investigation after receiving the complaint.Dhr of this concerned ceiling supply unit(csu) was reviewed.This unit was produced in jun of 2018, the dhr showed no any deviation identified from the manufacturing process and final release testing.Complaint historic data was also reviewed for any similar case reported in the past.Around (b)(4) units moduevo energy have been delivered since year 2016.Till now no similar complaint were received.When adjust the height of energy by handle, the screw rod moves upward or downward.When we put the hose on the brass nut, we found that the hose would not fall off during the movement, when the brass nut and the bearing housing bite, the hose gets stuck inside.So according this, it is concluded the hose was pulled into the screw rod when energy moves, and the hole in the o² hose was crushed when the brass nut bit the bearing housing.Maquet field service engineer cut the part with hole of the o2 hose, then re-connect the hose with a connector.Furthermore, the hoses were tied together with cable ties to make sure they will not be pulled into the screw rod when energy moves, to prevent the further damage.Maquet (b)(4) is collecting more detail information for further investigation, and the result will be provided in follow-up/final report.

Event Description

This problem was occurred in (b)(6), but since the similar product are sold to us, so we also need to this report.On (b)(6) 2019, getinge (b)(4) gmbh received a complaint from one hospital in (b)(6) that during surgery, when moving a ceiling supply unit, a hissing noise was heard very quickly.The oxygen supply via the ceiling supply unit failed.The doctor establishes patient safety by immediately switching the o² tube from the ceiling supply unit to the o² wall supply.On the same day, field service technician's visited this hospital.He observed o² hose was stuck between bearing housing and brass nut after he disassembled the cover of energy.Adjusting the energy and taking out the o² hose, he also observed there is a hole in the o² hose.It is obvious that a hissing noise is from the hole on the hose.No injury or death was reported.Manufacturer reference: (b)(4).

Manufacturer Narrative

Summary of investigation performed by maquet.Investigation at hospital by maquet field service technician, it could be observed o² hose was stuck between brass nuts and bearing when disassembled the cover of motor.According to the operational principle of energy and the observed defect, it is likely the hose was pulled into the screw rod when energy moves, and it was damaged by the force when the brass nut bit the bearing housing.Investigation at maquet suzhou: historic data review - as review on dhr for the concerned unit, it passed all the function testing including the gas pipeline test prior to release; complaint historic data was reviewed.Since this unit was delivered in june of 2018, there was no any feedback received during installation and after released to end user until now.It's believed this device could work as intended when it's put into use; complaint historic data was also reviewed for any similar reports.As checked, total 823 units moduevo energy placed in the market since initial launch in oct 2016.No similar complaints were received, this is first reported.Original energy design review, the life endurance test report for energy showed that after 9000 cycle movements the hoses were confirmed in good condition and no damaged was identified.It could be determined the design of motor structure is robust.Simulation test on demo products - investigation team checked the demo products at the facility which were installed similar as those in the field, and performed the simulation tests on these units as following; removed the cover of motor; removed the tie cable on the hoses to leave them flexible and loose; moved the energy up and down via pressing the button and observe the hose and the moving parts.It's observed that the hoses were not pulled or touched by the moving parts as they were kept a certain distance from each other.Then the hoses were pulled to be with longer length inside of motor to simulate the worst case, it's observed the hose could be touched.As the simulation test, it's possible that the hose was pulled and damaged by the moving parts if the hoses were not tied and left with long length part flexible inside of the motor.This is very unlikely as the service engineers commonly have the good managements on the flexible hose/cable by adding tie cable during installation.Conclusion, according to the above investigation, it could be concluded that the event was caused by inappropriate installation which results in the gas hose is damaged by moving parts (the gas hose is supposed to be tied and kept the distance from the moving part during installation, but not implemented as expected).Corrective action is done on 2019-06-19: 1 issue a newsletter to ssus to specify the requirements for energy pipelines installation and cable management; 2 update energy installation manual and manufacturing work instruction to specify requirements for pipelines installation and check after installation.

Event Description

Manufacturer reference: (b)(4).

• Brand Name: MAQUET
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): HELENA LU; maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502 4; CH 215024
• MDR Report Key: 8531312
• MDR Text Key: 145754916
• Report Number: 3007417753-2019-00001
• 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,foreign,health profe
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODUEVO(ENERGY)
• Device Lot Number: 7010007711
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1