MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO AT SYSTEM; MEDICAL MAGNETIC TAPE RECORDER

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

The artifact was most likely created by external electrical noise after the at system was removed from the patient's chest.

Event Description

False positive artifact transmission was sent to and read by the physician.

• Brand Name: ZIO AT SYSTEM
• Type of Device: MEDICAL MAGNETIC TAPE RECORDER
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 650 townsend; suite 500; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC; 650 townsend; suite 500; san francisco CA 94103
• Manufacturer Contact: rich laguna ; 650 townsend; suite 500; san francisco, CA 94103 ; 4156325701
• MDR Report Key: 7780722
• MDR Text Key: 117434994
• Report Number: 3007208829-2018-00023
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00869770000210
• UDI-Public: 00869770000210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2018

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: Health Professional
• Device Expiration Date: 07/16/2018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR