MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VS4 NBP, SPO2

Model Number 863283

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

The customer reported that the machine is broken due to a fall from unknown event.A good faith effort confirmed that the monitor was taken off the roll stand and place onto the patient's bed.The device was knocked off the bed from patient movements.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

Manufacturer Narrative

The customer contacted the customer care solutions center (ccsc) for assistance.Per the case notes, the device falling to the floor caused damage to the lcd, touch panel and navigation wheel.The philips remote support (rs) provided customer part numbers for front panel with touchscreen (453564357461), lcd/led display(453564357421), and navigation wheel board (453564517081).To repair the damaged parts reported by the customer, the replacement parts were ordered and sent to the customer.A good effort confirmed that the reported issue was caused by the user, therefore, this is not considered a malfunction of the device/roll stand mount.The device remains in use at the customer's facility.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: SURESIGNS VS4 NBP, SPO2
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15402135
• MDR Text Key: 302419148
• Report Number: 1218950-2022-00871
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2019
• 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