MAUDE Adverse Event Report: UNKNOWN INVACARE SLING; LIFT, PATIENT, NON-AC-POWERED

Model Number NOT AVAILABLE

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 12/27/2023

Event Type  Death  

Event Description

It was reported, that on (b)(6) 2023, a resident was being transferred using a sling, lift and transfer rail.During the transfer, the resident¿s right leg slipped beneath her causing her to fall on her right side.The resident sustained two bumps, one on the back of her head right side and one on her forehead right side.The resident¿s condition was monitored, but subsequently after a change of status and spasms of the right hemiface, the resident was sent to the hospital for a ct scan.The ct scan showed a subdural hematoma.The patient was hospitalized for monitoring and treatment of the spasms.The patient later died on (b)(6) 2023.

Manufacturer Narrative

On february 5, 2024, invacare was made aware of an event that occurred in france involving an invacare sling.It is unclear which model sling was involved in this incident and thus the manufacturer is unknown, therefore, for purposes of filing the invacare corporation oh/usa registration is being utilized.Due to the same slings may have been sold in the us this medwatch is being filed in an abundance of caution.The cause of the patient to fall has not been determined.A malfunction of the sling has not been alleged.This event may be the result of use error.Invacare france has requested additional information regarding this incident which includes: clarification of the sling model number, the lift model number and for a return of the product.If additional information becomes available a follow-up will be sent.

• Brand Name: INVACARE SLING
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): UNKNOWN
• Manufacturer (Section G): UNKNOWN
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 18827442
• MDR Text Key: 336794481
• Report Number: 1525712-2024-00003
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2024
• 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): Death