MAUDE Adverse Event Report: MAXHEALTH CORP. COMPASS HEALTH BRANDS; ALUMINUM ROLLATOR 6" WHEELS

Model Number RLA6BLF

Device Problems Labelling, Instructions for Use or Training Problem (1318); Material Separation (1562)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 06/13/2019

Event Type  Injury  

Event Description

The end-user was rolled in on an old rollator by her son into chb's customer's facility.Before the end-user transferred herself to the new rollator, chb's customer advised to make sure the brakes were locked before she sat down.Chb's customer turned her head and the end-user fell against a cabinet breaking her hip.It appeared that the left brake did lock and that the right possibly did not.The cable may have been more loosely attached to the brake on that side.Chb's customer received the rollator in the store and assembled it herself.She was instructing the end-user to make sure the brakes were engaged and she believes the end-user was already in the process of transferring to the device.Ems was called and came to get the end-user and was taken to a hospital.The device the end-user was transferring to is not a transport rollator.Chb's customer says it looked like the brake cable that goes into the silver component on right side appears to have pulled out slightly from the component.She does not recall if it was like that when she took it out of the box.She did not see the end-user or the son lock the right brake.The end-user's son took the rollator with them because he felt it could be fixed.The user manual states to inspect and test the device before transferring ownership of the product.It also states they must give the manual to the end-user of the product and that the end-user is to read the manual before using the device.

• Brand Name: COMPASS HEALTH BRANDS
• Type of Device: ALUMINUM ROLLATOR 6" WHEELS
• Manufacturer (Section D): MAXHEALTH CORP.; 14f, no. 99, section 1; xintai 5th road; xizhi district new taipei city, 22102 ; TW 22102
• MDR Report Key: 8772717
• MDR Text Key: 150455066
• Report Number: 3012316249-2019-00015
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RLA6BLF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2019
• Distributor Facility Aware Date: 06/14/2019
• Device Age: 15 MO
• Event Location: Other
• Date Report to Manufacturer: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 75