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

Catalog Number RQPH2704

Device Problems No Display/Image (1183); Moisture Damage (1405)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned.Incoming visual inspection found no anomalies.Technical evaluation identified liquid damage on the touch screen confirming the reported event of the touch screen not working.The case was checked for damage.The circuit boards were inspected.The touch screen assembly was replaced.The device was tested on a simulator.The display, nibp, on/off power, spo2, temperature, and the final visual inspection passed.Based on the reported event and device evaluation the root cause was determined to be user error as there was liquid damage identified.This type of event will continue to be monitored.

Event Description

Reportedly, post repair, the customer stated that the screen of the complaint device was not working.The device was not being used on a patient.No additional information is available.

• Brand Name: PHILIPS SURESIGNS VS4 VITAL SIGNS MONITOR
• Type of Device: BLOOD PRESSURE ALARM
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS, INC.; 3000 minuteman rd.; andover MA 01810 1099
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 8932282
• MDR Text Key: 177995726
• Report Number: 3007409280-2019-00009
• Device Sequence Number: 1
• Product Code: DSJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RQPH2704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1