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

Catalog Number CH0535C

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/14/2020

Event Type  Injury  

Event Description

Upon home health nurse visit on (b)(6) 2020 patient reported she was burned by the unit sensor on her upper outer left arm.Second degree burn noted, no medical treatment required by md or emergency department.Notified current health contact and was instructed to ship the unit back to the company for testing and evaluation.Shipped back to company on (b)(6) 2020 according to manufacture requirements.Reported up to home care/hospital risk management, senior leadership, patient physician, and all appropriate reports completed.All additional generation 2 current health telehealth systems removed from home care patients until evaluation and testing is completed by manufacturer.Manufacturer in full support of removing all units until testing completed.

• Brand Name: CURRENT HEALTH LTD SECOND GENERATION
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): CURRENT HEALTH LTD ; edinburgh ; UK
• MDR Report Key: 11076514
• MDR Text Key: 224100577
• Report Number: MW5098542
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CH0535C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 60