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

Model Number	863279
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Data correction to device identifier.
Additional Manufacturer Narrative
D4 product udi: the manufacturing date for the reported device is prior to 24sept2016 so no udi required.

• Brand Name: SURESIGNS VS2+ NBP/SPO2/WIRELESS
• Common Device Name: 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
• Report Number: 1218950-2023-00755
• Device Sequence Number: 7777347
• Product Code: DSK
• UDI-Device Identifier: 00884838028401
• UDI-Public: (01)00884838028401
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/15/2024

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
• Operator of Device: Health Professional
• Device Model Number: 863279
• Device Catalogue Number: 863279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Supplement Date Received by Manufacturer: 09/19/2023; 07/08/2024; Not provided
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/20/2023; 07/10/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown