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

Model Number INTELLIVUE MX40

Device Problems Failure to Power Up (1476); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

Telemetry unit would not turn on.The batteries were replaced, and unit still would not turn on.It was determined that the battery holding device was defective.The battery holder was replaced and the unit functioned.

• Brand Name: INTELLIVUE MX40
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 10477247
• MDR Text Key: 205145963
• Report Number: 10477247
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INTELLIVUE MX40
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/07/2020
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1