MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 TELEMETRY TRANSMITTER; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 865350

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/18/2023

Event Type  Death  

Event Description

Rn went to room to replace telemetry batteries and found patient unresponsive.Central monitoring indicated intermittent cardiac wavforms until the transmitter ceased functioning.Inspection of the device by manufacturer service engineer and clinical engineering revealed fluid intrusion in the battery tray likely causing the device to cease functioning.

• Brand Name: MX40 TELEMETRY TRANSMITTER
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; andover MA 01810
• MDR Report Key: 17661195
• MDR Text Key: 322398171
• Report Number: MW5145096
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/24/2023

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: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 89 YR
• Patient Sex: Prefer Not To Disclose