MAUDE Adverse Event Report: MEDIBO MEDICAL PRODUCTS NV MINSTREL; LIFT, PATIENT, NON-AC-POWERED

Model Number HMA0001

Device Problem Detachment Of Device Component (1104)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4).As of 2011, that number was de-activated due to the site no longer shipping product to the usa and until 2014 complaints related to these products were handled by arjohuntleigh, a branch of (b)(4) and any medwatch reports were submitted.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted.Additional information will be provided upon conclusions of the investigation.

Event Description

On 20th oct 2017, arjohuntleigh received information from (b)(6) indicating that during the using of the arjohuntleigh minstrel passive floor lift, the spreader bar was disconnected from the lift.As a result, the resident fell on the bed.No injury occurred.No medical intervention nor hospitalization was required.

Manufacturer Narrative

A product return to the responsible manufacturer was organized.We are waiting for the faulty part to be evaluated.Additional information will be provided upon evaluation of the faulty part and investigation completion.

Manufacturer Narrative

On 20th december 2017 a faulty component was received by the responsible manufacturer.The reported issue has been confirmed, a screw on spreader bar had been broken apart.Investigation is still in progress and additional information will be provided upon conclusion of the investigation.

Manufacturer Narrative

On (b)(6) 2017, arjo received information from (b)(6) indicating that during using of the arjo minstrel passive floor lift, the spreader bar disconnected from the lift because of broken screw.As a result, the resident (male, age (b)(6), weight (b)(6)) fell on the bed.No injury occurred.No medical intervention nor hospitalization was required.Based on the serial number (b)(4) provided, it was established that claimed device was manufactured in january 2010 by former manufacturer medibo medical products located in (b)(4).The evaluation of spreader bar confirmed that the detachment was caused by breakage of the bolt.Arjo conducted an comprehensive investigation towards reported product malfunction: the analysis of device construction revealed that the connection between spreader bar and jig prevented from rotation in all axis, as the solution had only two degrees of freedom.The bolt connecting the spreader bar and jig was subjected to bending tension.In the long term use and without regular preventive maintenance performed, because metal fatigue and the formation of micro-cracks in the thread occurred, this eventually led to the destruction of the bolt.Bending tensions may be created when e.G.Load mass is unevenly placed on sling, caregiver move lift by pushing/pulling suspended patient body, sling or spreader bar.In the reported event, it was confirmed by an arjo technician that, the lift involved in the incident was in an overall bed condition.The device was not under arjo service/maintenance contract.A customer refused twice (in 2016 and 2017) an arjo offer of preventive maintenance of this device.Product instruction for use (ifu) dated january 2009 states that: "the operational life of the minstrel and its accessories e.G.Stretcher, etc.Is dependent on the actual use condition.Therefore before use, always make sure that the lift is safe to use and has not been damaged.If any damage should be observed, do not use the minstrel"."arjohuntleigh recommends that minstrel is maintained at regular intervals." in preventive maintenance schedule section, ifu warns: "continuing to use this product without conducting regular inspections or when a fault is found will seriously compromise the user and residents' safety.[.] preventive maintenance specified in this manual can prevent accidents".Everyday action includes "making sure all external fittings are secure and that all screws and nuts are tight".After reviewing all the information available, it was determined that the overall bad condition of the device and lack of preventive maintenance cannot be excluded as having significant impact on the device malfunction.When reviewing the reportable events for minstrel floor lift registered during last 5 years, we have found a limited number of cases related to the failure of the bolt holding the spreader bar.The spreader bar disconnected from the lift during the resident's transfer so the system was not up to the manufacturer's specification.This complaint decided to be reportable based on the potential for injury if the spreader bar disconnection would to re-occur during transfer with a resident.

Manufacturer Narrative

It was established that claimed device was manufactured in 2010 by former manufacturer medibo medical products located in (b)(4), which indicates previous version of the device with an old design of spreader bar.In the previous design, the bolt connecting the spreader bar and jig was subjected to bending tension.In the long term use and without preventive maintenance performed by the customer, it could be a contributing factor to a bolt breakage.Corrective action decision is pending determination.Additional information will be provided upon conclusion of the investigation.

• Brand Name: MINSTREL
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont-achel, BE-39 30; BE BE-3930
• MDR Report Key: 7031993
• MDR Text Key: 93376265
• Report Number: 3007420694-2017-00215
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/18/2018

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
• Device Model Number: HMA0001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2018
• Distributor Facility Aware Date: 10/20/2017
• Device Age: 7 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/18/2018
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 10/20/2017; 12/20/2017; 02/01/2018; 05/24/2018
• Supplement Dates FDA Received: 12/14/2017; 01/17/2018; 03/02/2018; 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 82