MAUDE Adverse Event Report: HANDICARE AB CARINA LIFTS; LIFT, PATIENT, NON AC-POWERED

Model Number 350EE, 350EML, 350EM

Device Problems Material Separation (1562); Defective Component (2292); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 05/21/2016

Event Type  malfunction  

Manufacturer Narrative

This incident occurred in (b)(6).No similar incident has occurred in u.S.According to handicare (b)(4) records.The damage is believed to be caused by assembly of wrong sized locking pin into the actuator of the device.Handicare (b)(4) will investigate this issue further and take necessary precautions.No health hazard evaluation (hhe) is attached to this mdr report due to incomplete information.Handicare (b)(4) has concluded that no information of significance can be provided through an hhe at this time.

Event Description

The device was used by domiciliary care staff in (b)(6) to transfer patient from floor.They heard a loud noise from the lift as they raised the patient with the lift.That was when metal parts surrounding the pin-hole between actuator and lift-arm broke.The locking pin came off the actuator which caused the lift-arm to collapse and the patient using the device fell to the floor whilst in the sling.The patient received immediate support from paramedics and was sent to undergo medical examination by ambulance.The patient was later discharged with pain relief.The device was immediately taken out of service and placed in another room and all staff were advised not to use it.

Manufacturer Narrative

3009481053-2016-00003 initial report was submitted on 22jun16.A follow up report was submitted on 19aug16 using a different report number, 3009481053-2016-00007, in error.In section g "follow-up #1" was checked.However, 3009481053-2016-00003 should have been referenced.We were notified of this error by (b)(6) on 30sept20.This report is a follow up to 3009481053-2016-00003 using the information from 3009481053-2016-00007.Manufacturer narrative from 3009481053-2016-00007: it has come to handicare ab's knowledge that wrong sized locking pins (diameter 7.5 mm) were mounted onto the actuators of carina mobile lifts during manufacturing from may 2015 until january 2016.Carina mobile lifts manufactured before and after this period are not affected by this error.Internal investigation has shown that the wrong sized locking pin may cause signs of wear on the plastic bushings attached to the locking pin and possibly also signs of wear on the metallic piston rod eye of the actuator.The investigation showed that there is a very small risk that the locking pin would cause further damage to the device.As the affected devices have been on the market for 1 year and 3 months at most, it is not believed that the wear damage would grow severe enough to represent a serious health hazard to patients.No patient injury has occured due to this error.Nevertheless, handicare ab has initiated a recall to correct the affected carina mobile lifts.The purpose of the recall is to exchange wrong sized locking pins with correctly sized locking pins (diameter 10 mm).The recall number is z-0014-2018.

Event Description

Handicare ab has previously submitted an mdr initial report (manufacturer report number 3009481053-2016-00003) for this event which occured in northern ireland.The event concerned a carina mobile lift which was equipped with a too small locking pin (diameter 7.5 mm).As the event occured in northern ireland, the health and safety executive (hse) conducted an investigation of the actual device.Their investigation showed that the locking pin was not correctly mounted on the actuator of the carina mobile lift, which in turn caused device damage that led to the locking pin dislodging from the actuator and the lift-arm to come off.They concluded that the event was caused by user error.

• Brand Name: CARINA LIFTS
• Type of Device: LIFT, PATIENT, NON AC-POWERED
• Manufacturer (Section D): HANDICARE AB; torshamnsgatan 35; maskinvägen 17; kista, 16440 ; SW 16440
• MDR Report Key: 5945441
• MDR Text Key: 54527297
• Report Number: 3009481053-2016-00003
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 350EE, 350EML, 350EM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0014-2018
• Patient Sequence Number: 1