MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4 NBP, SPO2

Model Number 863283

Device Problem Device Fell (4014)

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

Event Date 07/13/2021

Event Type  malfunction  

Event Description

The customer reported that the monitor screen is broken because it fell onto the ground.The device was not in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.

Event Description

The customer reported that the monitor screen is broken because it fell onto the ground.The device was not in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.

Manufacturer Narrative

This supplemental report is created with reference to mfg report with corrected information to update the manufacturing site.

Event Description

The customer reported that the monitor screen is broken because it fell onto the ground.The device was not in clinical use at the time the reported issue was discovered.No adverse event involving a patient or user was reported by the customer.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: SURESIGNS VS4 NBP, SPO2
• 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: tara mackinnon ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 12218871
• MDR Text Key: 263187222
• Report Number: 1218950-2021-10744
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K163649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/13/2021
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 07/13/2021; 07/13/2021
• Supplement Dates FDA Received: 08/19/2021; 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2018
• 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