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U.S. Department of Health and Human Services

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

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CURRENT HEALTH LTD CURRENT HEALTH LTD SECOND GENERATION TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Back to Search Results
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.
 
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Brand NameCURRENT HEALTH LTD SECOND GENERATION
Type of DeviceTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Manufacturer (Section D)
CURRENT HEALTH LTD
edinburgh
UK
MDR Report Key11076514
MDR Text Key224100577
Report NumberMW5098542
Device Sequence Number1
Product Code DRG
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCH0535C
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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