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

Model Number 863380

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Data Problem (3196)

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

Event Date 09/06/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The vs30 was in interval mode, manual blood pressure was taken and the save now was selected.The incorrect data transmitted to a different patient's chart and incorrect assumptions were made about treatment of the patient until the staff noticed the error.The vs30 sends patient data to the emr in interval/continuous mode with the selection of savenow and no lockout period for operator.The device was in use on a patient.There was no report of patient or user harm.

Event Description

The customer reported that the incorrect data was transmitted to a different patient's chart.This resulted in incorrect assumptions being made about the treatment of the patient until the staff noticed the error.The device was in use on a patient.There was no report of patient or user harm.The philips remote service engineer (rse) confirmed the event.The issue is currently still being investigated by philips.The rse noted that the monitor is not logging the operator off when same operator id duration is turned on and set to a specific time period.There will be additional information provided following completion of the investigation.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that data was transmitted to the incorrect patient's chart.This resulted in incorrect assumptions being made about the treatment of the patient until the staff noticed the error.The device was in use.There was no report of patient or user harm.

Manufacturer Narrative

A philips clinical solutions workflow consultant confirmed the issue.Philips worked with the customer to validate the stated behavior and discussed alternatives to mitigate the problem with patient id validation, placing the monitor in standby over night and changing modes.A philips remote service engineer (rse) is working with philips r&d to further investigate the issue.The rse noted that the monitor is not logging the operator off when same operator id duration is turned on and set to a specific time period and that it seems to be a software or configuration issue.A good faith effort attempt was made to obtain additional information regarding this investigation but has been unsuccessful to date.No additional information is available.The customer was provided with work around options.No further investigation or action is warranted at this time.

• 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
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15543630
• MDR Text Key: 301194553
• Report Number: 9610816-2022-00512
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838091412
• UDI-Public: 00884838091412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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: 863380
• Device Catalogue Number: 863380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 11/04/2022; 11/04/2022
• Supplement Dates FDA Received: 11/21/2022; 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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