MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30 VITALS MONITOR

Model Number 863380

Device Problem Device Fell (4014)

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

Event Date 07/29/2021

Event Type  malfunction  

Event Description

The customer reported that the device screen is broken from a fall.It is unknown if the device was in use on patient at time of event.No adverse event involving a patient or user was reported by the customer.

Event Description

The customer reported that the device screen is broken from a fall.It is unknown if the device was in use on patient at time of event.No adverse event involving a patient or user was reported by the customer.

• Brand Name: EARLYVUE VS30 VITALS MONITOR
• Type of Device: EARLYVUE VS30 VITALS MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 12296049
• MDR Text Key: 265656509
• Report Number: 9610816-2021-10275
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838091412
• UDI-Public: 00884838091412
• Combination Product (y/n): N
• PMA/PMN Number: K190624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• 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: 863380
• Device Catalogue Number: 863380
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/29/2021
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 07/29/2021
• Supplement Dates FDA Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1