MAUDE Adverse Event Report: CURRENT HEALTH LTD. CURRENT_HEALTH_WEARABLE_V2; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Patient Problem Insufficient Information (4580)

Event Date 03/29/2024

Event Type  Death  

Event Description

Patient found deceased in home wearing continuous monitoring device, malfunctioned."best buy health, boston, ma 02210, us.Soft horse five and alert dill three.Manufacturer is samsung: soft horse five current_health_tablet - (manufacturer is samsung).Manufacturer is best buy health, current health of the below products: soft horse five current_health_wearable_v2.Current_health_homehub alert dill three.Ihealth_bp5s." reference reports: mw5154020, mw5154021, mw5154022.

• Brand Name: CURRENT_HEALTH_WEARABLE_V2
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): CURRENT HEALTH LTD.
• MDR Report Key: 19151686
• MDR Text Key: 340702733
• Report Number: MW5154019
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CURRENT_HEALTH_HOMEHUB; CURRENT_HEALTH_TABLET; IHEALTH_BP5S
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 137 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American