MAUDE Adverse Event Report: NINGBO BEHEALTHY TECHNOLOGY GROUP CO., LTD. JIN MASSAGE CHAIR; MASSAGER, THERAPEUTIC, ELECTRIC

Model Number JHTW-JIN-BRN

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/09/2023

Event Type  Death  

Event Description

A father of a two-year old child had placed a jin massage chair very close to a work desk.The father was using the massage chair in his home office so that he could work and receive a massage simultaneously.The father left the room and a two-year old child was left unsupervised with the massage chair for a period of approximately 7 minutes.It appears that the child operated the jin massage chair in his father's absence, causing the chair to recline and the foot rest (ottoman / leg massager feature) to move upward.This placed the ottoman / leg massager portion of the chair into close proximity with the office desk.It appears that the child's neck became entrapped between the edge of the work desk and the ottoman / leg massager portion of the chair.The cause of death is alleged to be entrapment and/or crushing of the child between the edge of the desk and the edge of the ottoman / leg massager portion of the chair.Investigation into the root cause of this event is ongoing.The investigation to-date has not identified a malfunction with the chair that could have caused or contributed to the death.This matter was brought to the attention of the importer by a plaintiff's attorney hired to represent the family of the deceased two-year old boy.The plaintiff's attorney has told the insurance company for the importer that there is nothing wrong with the function of the chair.

• Brand Name: JIN MASSAGE CHAIR
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): NINGBO BEHEALTHY TECHNOLOGY GROUP CO., LTD.; ningbo city, zhejiang province ; CH
• MDR Report Key: 18949375
• MDR Text Key: 338236039
• Report Number: 3015920609-2024-00001
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JHTW-JIN-BRN
• Device Catalogue Number: INNER BALANCE WELLNESS JIN MAS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2023
• Device Age: 3 YR
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 24 MO
• Patient Sex: Male