MAUDE Adverse Event Report: SCHILLER SCHILLER MONITORING SYSTEM; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number PB-1000

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

(b)(6) rep reported that they had an interference issue between their patient monitoring system and the aex unit during a case.There was "noise" on the ekg readings that were falsely interpreted as a-flutter.They do not know if the issue came from the monitoring system (schiller pb-1000) or the aex unit.Sn: unknown (could be (b)(6)) site does not know.Medtronic reference number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SCHILLER MONITORING SYSTEM
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): SCHILLER
• MDR Report Key: 17488480
• MDR Text Key: 320695359
• Report Number: MW5121179
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2023

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?: No
• Device Model Number: PB-1000
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1