MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VSI - NBP/SPO2; PATIENT MONITOR

Model Number 863276

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A philips response center engineer (rce) spoke with the customer and confirmed the issue.There is an impact on the front panel and a black spot on the lcd screen.The rce provided the information to send the device to workshop.There was no additional information regarding this evaluation.It is unknown if the device remains in use at the customer site, or how the issue was resolved.There have been no subsequent calls logged for this device/issue.This mdr is being submitted as part of a batch submission of previously closed service orders that were reclassified as complaints; discovered as part of a retrospective remediation review.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

The customer reported that apparently the device has fallen.The device was in clinical use at the time the issue was discovered.There was no adverse event or patient harm reported.

• Brand Name: SURESIGNS VSI - NBP/SPO2
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: kimberly shelly ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 11715237
• MDR Text Key: 249430459
• Report Number: 1218950-2020-07206
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863276
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2015
• 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