MAUDE Adverse Event Report: HALO MOBILITY SOLUTIONS LLC HALO SAFETY RING BED GRAB HANDLE; BED, MANUAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Strangulation (2084)

Event Date 01/28/2022

Event Type  Death  

Event Description

Resident passed away while in healthcare facility.Resident had a halo grab handle on bed from comfort company and cause of death is accidental due to strangulation with grab handle.Fda safety report id# (b)(4).

Event Description

Additional information received from reporter on 2/18/2022 for report mw5107117.Comfort company (b)(4).

Event Description

Additional information received from reporter on 2/18/2022 for report mw5107117.Comfort company (b)(4).

• Brand Name: HALO SAFETY RING BED GRAB HANDLE
• Type of Device: BED, MANUAL
• Manufacturer (Section D): HALO MOBILITY SOLUTIONS LLC; 10125 lady apple drive; las vegas NV 89148
• MDR Report Key: 13424120
• MDR Text Key: 284986886
• Report Number: MW5107117
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White