MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ARIA TRANSMITTER WITH SP02 TRUNK CABLE; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 2382 TRANSMITTER NUMBER

Device Problems Overheating of Device (1437); Device Sensing Problem (2917)

Patient Problem Burning Sensation (2146)

Event Date 10/28/2020

Event Type  malfunction  

Event Description

The aria telemetry monitor with sp02 trunk cable was on patient.The patient complained of monitor becoming hot on his chest wall.The screen went out and showed signal loss.This is not the first time we have addressed this issue.Spacelabs is already in the process of an investigation for this same issue.All supplies involved in this event were sent to spacelabs.Fda safety report id: (b)(4).

• Brand Name: SPACELABS ARIA TRANSMITTER WITH SP02 TRUNK CABLE
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.
• MDR Report Key: 10785098
• MDR Text Key: 214777197
• Report Number: MW5097626
• Device Sequence Number: 1
• Product Code: MHX
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2382 TRANSMITTER NUMBER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2020
• 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