MAUDE Adverse Event Report: ARJO HUNTLEIGH ARJOHUNTLEIGH; MAXI MOVE LIFT

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Fall (1848)

Event Date 12/23/2017

Event Type  Death  

Event Description

Resident was being mechanically lifted using maxi-move lift from bed to wheelchair with 2 staff present as resident was 3-4 feet off ground.The right shoulder key-hole clip detached and resident feel headrest onto floor.Resident died on (b)(6) 2017.

Event Description

Resident was being mechanically lifted using maxi - move lift from bed to wheelchair with 2 staff present.As resident was 3-4 ft off ground the right shoulder key-hole clip detached and resident fell head first onto floor.Resident sent to 911 to (b)(6) and admitted with fractures right 1st and 2nd ribs and compression fractured l1+l2.Resident hospitalized from (b)(6) 2017.In april 2018, the dept of public health did an investigation and it resulted with no citations.

• Brand Name: ARJOHUNTLEIGH
• Type of Device: MAXI MOVE LIFT
• Manufacturer (Section D): ARJO HUNTLEIGH
• MDR Report Key: 7205971
• MDR Text Key: 97860981
• Report Number: 7205971
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2018
• Distributor Facility Aware Date: 12/23/2017
• Device Age: 9 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 83 YR
• Patient Weight: 59