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

Device Problems Battery Problem (2885); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 12/02/2019

Event Type  malfunction  

Event Description

While attempting to take a scheduled blood pressure reading for the patient the bedside monitor displayed a "replace battery immediately" error message and would not allow the clinician to take a blood pressure.The monitor was plugged into ac power, but the error message caused the bp monitor to freeze and not allow any user interface action.Monitor was removed from service and sent to biomedical for evaluation.Biomedical removed the rechargeable battery pack and pressed the self check key and noted that the battery charge indicator showed 100% charge.Re-insertion of the battery back into the monitor created the "remove battery immediately" message.A new battery replacement was inserted into the monitor with no additional error messages.This was the second incident of this type of failure in the last two weeks on the same model and age of monitor about 11 months into service.The battery lot numbers were the same on both batteries.These li-ion batteries were to have a 36 month service life.Manufacturer response for battery, li-ion 11.1vdc, 7.8ah, molicel (per site reporter) manufacturer to arrange to have battery analysed.Manufacturer response for monitor, vital signs, suresigns vs4 (per site reporter) manufacturer to assist in determining cause.Batteries help for their analysis.

• Brand Name: SURESIGNS VS4
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT ARRHYTHMIA DETECTION OR ALARMS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9495103
• MDR Text Key: 172005264
• Report Number: 9495103
• 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: 12/05/2019

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?: Yes
• Device Operator: Health Professional
• 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: 12/05/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3650 DA