MAUDE Adverse Event Report: INVACARE TAYLOR STREET RMA-RECLINERS AND LIFTS; LIFT, PATIENT, AC-POWERED

Model Number NA:PATIENTTRANS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 05/16/2021

Event Type  Injury  

Event Description

Per lawyers letter, end user fell during a transfer while using a non invacare lift, maxi sky 440 while in an invacare sling.It is not documented what sling was being used.The legal document stated that the user sustained a traumatic brain injury, as well as spraining, straining and tearing of the muscles, tendons, ligaments and nerves throughout his body.It goes on to say the injuries are accompanied by headaches, serious cognitive dysfunction, dizziness, shock, anxiety, depression, emotional trauma, chronic pain, insomnia, weakness, diminished energy and stiffness.As well as extensive hospital, medical, surgical, therapeutic, pharmaceutical and other treatment was obtained.No further details describing the exact injuries or treatment was given.

Manufacturer Narrative

This issue is being reported in an abundance of caution due to the allegation of serious injury relating to a non invacare patient lift with an invacare sling.It is unclear what, if any malfunction involving the invacare sling occurred.The invacare sling owners manual, pn 1023891-k (b)(6) 2018, states, "invacare slings are made specifically for use with invacare lifts.For the safety of the patient, do not intermix slings and lifts of different manufacturers".Due to no information available regarding the actual sling the actual manufacturer & manufacturing date are unknown.For filing purposes the manufacturing location has been selected as taylor street.Should any new information become available, a follow up will be filed.

• Brand Name: RMA-RECLINERS AND LIFTS
• Type of Device: LIFT, PATIENT, AC-POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 15944063
• MDR Text Key: 305137832
• Report Number: 1531186-2022-00006
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: NA:PATIENTTRANS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization
• Patient Sex: Male