MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Problems Melted (1385); Overheating of Device (1437); Battery Problem (2885)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2020

Event Type  malfunction  

Event Description

Since 2015, we have purchased numerous philips suresigns vs4 vital signs monitors.Each monitor comes with shock absorbing rubber feet on the bottom of the monitors.The shock absorbing rubber feet have been melting due high heat produced by the battery, thus becoming a glue-like substance that once it sticks to the floor or fingers, it's very hard to clean or peel off from the skin.We have purchased several batteries and replaced them, but the issue has not been resolved as it is continue to occur.

• Brand Name: SURESIGNS VS4
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11306732
• MDR Text Key: 231131336
• Report Number: 11306732
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/08/2021,02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1