MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS, INC. SURESIGNS VS4; MONITOR, VITAL SIGNS

Catalog Number 863283

Device Problems Use of Incorrect Control/Treatment Settings (1126); Self-Activation or Keying (1557); Inappropriate or Unexpected Reset (2959)

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

Event Date 04/04/2019

Event Type  malfunction  

Event Description

While connecting and setting the patient on a vital signs monitor with nbp, spo2, and temp, the rn set the alarm limits for spo2 sat, and pulse rate for the patient.While the clinician was attending to the patient, the monitor alarmed low pulse and reverted back to the programmed default values.For example, when spo2 is set and saved for a low sat of 85 and the low pulse rate set for 65, the patient is monitor at 95 sat and a pulse rate of 70-72.The monitor suddenly alarms "pulse low" and reverts back to default setting of low sat 90 and low pulse 75.This alert occurs between 18 and 120 seconds.This issue is occurring on all recently purchased (95 each) vital signs monitors place into service in the last 4 months.Biomedical is unable to determine what is causing the default reverts which should only occur when monitor powered off, changing patient population profile, or physically changing each measurement limit.Biomedical tried to change the alarm limit after default reset but the same alert and default reset occurred.Biomedical advising clinical team to select safe default parameters and provide additional patient monitoring until issue is resolved by manufacturer.The monitor still gives accurate spo2 and nbp readings.Manufacturer notified id defaulting issues and biomedical to open work request with mfg.Manufacturer response for monitor, vital signs, suresigns vs4 (per site reporter).Manufacturer rep informed us to contact manufacturer service sent to open up case and report event.This is the first that they have heard of this issue.

• Brand Name: SURESIGNS VS4
• Type of Device: MONITOR, VITAL SIGNS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS, INC.; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8531086
• MDR Text Key: 142480646
• Report Number: 8531086
• 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: 04/07/2019,04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 863283
• 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: 04/07/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3285 DA