MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS2+ NBP/SPO2/WIRELESS

Model Number 863279

Device Problem Device Fell (4014)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that the equipment came off the cart and fell to the floor.The device was not in use on a patient at the time of the event.

Manufacturer Narrative

A philips remote service engineer (rse) remotely interviewed the customer who was onsite.The customer confirmed the torx screw was loose.The rse dispatched a philips field service engineer (fse) to the location.The fse checked the equipment, and the anchoring system was adjusted to the rolling cart to resolve the issue.The fse noted there was nothing abnormal, apart from a missing screw and loose screws on cart fixation to suresign.Based on the information available and the testing conducted, the cause of the reported problem was confirmed to be the anchoring system.After the fse evaluated the unit and the anchoring system was adjusted to the rolling cart, the device was returned to functional use with no further issues identified.The device remains at the customer site.No further investigation or action is warranted at this time.

• Brand Name: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• Type of Device: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17908429
• MDR Text Key: 325491682
• Report Number: 1218950-2023-00755
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00884838028401
• UDI-Public: 00884838028401
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K111114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Device Model Number: 863279
• Device Catalogue Number: 863279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• 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