MAUDE Adverse Event Report: ARJOHUNTLEIGH MAGOG INC. V4-I; LIFT, PATIENT, NON-AC-POWERED

Device Problems Detachment Of Device Component (1104); Installation-Related Problem (2965)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Arjohuntleigh received a complaint where it was indicated that the v4-i ceiling lift fell down off the kwiktrak rail installation.During the time of incident, the device was not being used with a patient.No harm was reported.In light of reported information, the event occurred when the caregivers were moving the ceiling lift along the ceiling lift rail to do a client transfer.The lift was reported to be jammed and could not move to the intended position on the rail.Finally, the lift was pushed by the caregiver to the end of the track where it fell out.The rail was inspected by arjohuntleigh representative.No sign of trolley wear to indicate a "jam" as per original issue.The track was in very good condition.We (arjohuntleigh) have been able to establish that the failure resulted from the fact that the component which is intended to stop the lift at the end of the track - "end stopper" - was missing.When reviewing similar reportable events, we have found limited number of cases that may relate to the issue investigated here: non-portable ceiling lift detaches from the end of the track due to a missing end stopper.We have been able to establish that compared to the amount of sold devices and in comparison to their daily use, there is no trend observed for reportable complaints with this failure and the occurrence rate is low.Upon the course of the investigation, it was established that a common practice in this facility is to remove and install ceiling lifts on rails in other rooms.It seems very probable that after installation of the ceiling lift, the user forgot to install the end stopper and end cap at the end of track.According to the information gathered, there are two likely factors that lead to detachment of the ceiling lift: the customer itself performed installation of the ceiling lift and left the track rail with a missing component: end stopper.As per ifu (001.14150 rev.5) "always reinstall the rail end stopper (if it has been removed) after servicing." the caregiver also proceeded to use of the ceiling lift with missing track components.As per the ifu of the ceiling lift, the caregiver is obligated before every use "make sure end stoppers are properly installed." to sum up, the cause of the incident is therefore considered to be an incorrect installation of the end stopper component at one end of the ceiling rail and also an incorrect maintenance activity, related to using the ceiling lift at the track system which had a missing stopper.It will be recommended to perform re-training for the customer with the contents of the ifu as supplied with the ceiling device.While the incident occurred the device was not being used for treatment or diagnosis the patient.The ceiling rail system was not up to the manufacturer specification when the event took place.The complaint decided to be reportable in abundance of caution, based on the potential of patient/caregiver injury if the resident would be attached on the device and the ceiling lift would move through the unsecured end of the installation track and fall down.

Event Description

Arjohuntleigh received a complaint where it was indicated that the v4-i ceiling lift fell down off the kwiktrak rail installation.During the time of incident, the device was not being used with a patient.No harm was reported.In light of reported information, the event occurred when the caregivers were moving the ceiling lift along the ceiling lift rail to do a client transfer.The lift was reported to be jammed and could not move to the intended position on the rail.Finally, the lift was pushed by the caregiver to the end of the track where it fell out.The rail was inspected by arjohuntleigh representative.No sign of trolley wear to indicate a "jam" as per original issue.The track was in very good condition.We (arjohuntleigh) have been able to establish that the failure resulted from the fact that the component which is intended to stop the lift at the end of the track - "end stopper" - was missing.

• Brand Name: V4-I
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X5Y 5; CA J1X5Y5
• Manufacturer (Section G): ARJOHUNTLEIGH MAGOG INC.; 2001 tanguay street; magog, quebec J1X5Y 5; CA J1X5Y5
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6581130
• MDR Text Key: 75628025
• Report Number: 9681684-2017-00038
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 05/22/2017

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: Other Caregivers
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2017
• Distributor Facility Aware Date: 05/16/2017
• Device Age: 12 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/22/2017
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other