MAUDE Adverse Event Report: MERITS HEALTH PRODUCTS CO., LTD MERITS HEALTH PRODUCTS CO., LTD; PILOT NAVIGATOR

Model Number E60421YLMUB

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Bruise/Contusion (1754)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Base on the provided s/n, we checked the final inspection record and it was confirmed that it pass our final inspection.After reviewing the failure parts, we found that was swing head assembly was stuck due to the damaged bearing.The needle bearing fall out from the bearing retainer.The bearing outside case was also slightly deformed by a screw which went through a hole on the top of the swing head assembly.After investigating the problem, we found the root cause to this failure is as below: (1) the tolerance between the swing head hole and the bearing was too big or the insufficient roundness which cause the bearing might be rotating inside the hole and prematurely fail.(2)the screw which went through the hole on the top on the swing head was overtightened and damage the bearing case.Base on our initial investigation, our improvement plan is as below: revise the hole tolerance of the swing head hole.Cancel the screw which went through the swing head hole and replace it with a welded nut, to avoid the damage on the bearing.Upgrade the bearing from stamping to machining type.We will conduct further verification and validation action for this improvement and also will start to work on our repair plan for the sold units in the field.

Event Description

User was riding from first floor to the second when approximately halfway along the track, the pinion gear disengaged from the gear rack allowing the lift to slide downward.The pinion gear re-arranged with the gear rack approximately half of the initial travel bringing the lift to a slop.The user was shaken by the malfunction and suffered minor bruising to his arm, no hospitalization was required.

Manufacturer Narrative

This is a follow up report to update our status.In order to follow up, we have issued internal capa and also conducted the validation tests.(see appendix i for the capa form no.20201002 and related test reports attached).Now it is confirmed that the improvement is effective so we are now starting to plan for the field correction.Our usa local distributor has sent notification letter to the customers.The letter identified the affected product and requested the customers to complete the form.Due to the coronavirus outbreak, there will be a delay on the implementation of the field correction and information was pass out accordingly.- attachment: [20201002 capa 22020-3-25 eng v1.Pdf, appendix 7 of capa (rar-e03-02) risk management report.Pdf].

Event Description

User was riding from first floor to the second when approximately halfway along the track, the pinion gear disengaged from the gear rack allowing the lift to slide downward.The pinion gear re-arranged with the gear rack approximately half of the initial travel bringing the lift to a slop.The user was shaken by the malfunction and suffered minor bruising to his arm, no hospitalization was required.

• Brand Name: MERITS HEALTH PRODUCTS CO., LTD
• Type of Device: PILOT NAVIGATOR
• Manufacturer (Section D): MERITS HEALTH PRODUCTS CO., LTD; no. 18. jingke rd,tpmt park,; nantun district; taichung city, 40852 ; TW 40852
• MDR Report Key: 9765465
• MDR Text Key: 221282215
• Report Number: 9680333-2020-00001
• Device Sequence Number: 1
• Product Code: PCD
• UDI-Device Identifier: 04714379292015
• UDI-Public: 04714379292015
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: E60421YLMUB
• Device Catalogue Number: E60411-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2019
• Device Age: 14 MO
• Event Location: Home
• Date Report to Manufacturer: 02/06/2020
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly
• Patient Age: 65 YR
• Patient Weight: 86