MAUDE Adverse Event Report: DOLOMITE ROLLATOR FUTURA-600-HP-L BLACK; WALKER, MECHANICAL

Model Number EU:12082-43-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Strangulation (2084)

Event Date 01/02/2022

Event Type  Death  

Event Description

The end-user was using a futura rollator.When the staff went to get her for lunch, they said she was bent forward, with her head under the rollator.When they lifted the patient, the collar around their neck loosened, but there were no signs of life.The staff reported that the patient's sweater was attached to the screw used to adjust the height of the handles on the rollator.The rollator was standing on all 4-wheels, and they didn't report any malfunction.

Manufacturer Narrative

Invacare is filing this medwatch in an abundance of caution due to the severity of the outcome.This event in occurred in (b)(6) involving a dolomite futura rollator.Invacare is filing this report because the device is also sold in the u.S.This device was manufactured at invacare (b)(6) in (b)(6) 2019.It has been requested the device be returned for an investigation.As of 2/21/2022, the rollator has not been received.No further information about the incident has been obtained.Based on the information provided, it is unclear what, if any malfunction occurred.Should additional information become available, a supplemental record will be filed.

• Brand Name: ROLLATOR FUTURA-600-HP-L BLACK
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE; box 200; vaxjovagen 303; dio 34375 ; SW 34375
• Manufacturer (Section G): INVACARE REA AB; växjövägen 303; diö 343 7 1; SW 343 71
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 13579751
• MDR Text Key: 285958412
• Report Number: 9615290-2022-00001
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2022

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: Lay User/Patient
• Device Model Number: EU:12082-43-01
• Device Catalogue Number: ROLLATOR FUTURA-600
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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
• Patient Sex: Female