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

Model Number HMA001

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusions of the investigation.

Event Description

Arjo received the information about incident from the arjo distributor (b)(4) indicating that during the use of the arjo minstrel passive floor lift, the spreader bar was disconnected from the lift.As a result, the resident fell on the bed.The patient was sent to hospital for tests.No injury was reported to the patient and no further treatment was required.

Manufacturer Narrative

Arjo received an information from the arjo distributor in israel (hagai medical and nursing) indicating that during use of the arjo minstrel passive floor lift with a patient, the spreader bar (part on which patient and the sling are attached on) disconnected from the lifting arm.As a result, the resident fell on the bed and was sent to a hospital.No further treatment nor hospitalization was required because no injury occurred.During the inspection of the involved device performed by the device's distributor, it was confirmed that the detachment of the spreader bar was caused by breakage of the bolt located between the spreader bar and the lifting arm.The faulty part has never been subjected to service nor repair.At the time of the incident, the involved floor lift was over 12 years old and exceeded its 10-years labeled lifetime two years ago.The instruction for use (ifu, mmx15030.Gb rev.1) contains the following information: "the expected operational life of the minstrel is ten years, providing it has been regularly serviced and maintained as recommended." analysis of the data provided revealed that the mechanical failure is probable to occur due to wear of the bolt (the long-term use could create a metal fatigue and a formation of micro-cracks in the thread) and bending tension which can occur when user is not following the ifu warnings and instructions (e.G.Load mass was unevenly placed on sling; or lift moved by pushing/pulling suspended patient body, sling or spreader bar).To avoid this kind of issues, the device owner is obligated to follow the ifu delivered with each equipment.As per ifu "a general visual inspection of all external parts should be carried out, and all functions should be tested for correct operation, to ensure that no adverse damage has occurred during use." if any problem occurs before use, the device should be excluded from use until will be repaired.There is a very low possibility of any potentially risky situation to occur if the device's owner follows every guideline given in the device ifu and regularly servicing the device.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 of injury if the spreader bar disconnection would to re-occurre during transfer with a resident.

• 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: 7521268
• MDR Text Key: 108501945
• Report Number: 3007420694-2018-00108
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

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: HMA001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2018
• Distributor Facility Aware Date: 04/26/2018
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2018
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 04/26/2018
• Supplement Dates FDA Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization