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

Model Number 863380

Device Problems Use of Incorrect Control/Treatment Settings (1126); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  Injury  

Event Description

It was reported during the non-invasive blood pressure (nibp) function, the device was overinfalting, causingthe patient to bruise.The device was in clinical use, and the patient required medical attention.

Manufacturer Narrative

Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

A philips remote service engineer (rse) spoke by telephone support with the customer.The customer troubleshooted the device and the nbp kept pumping and reached high intervals.The customer cleared the reports and the nbp worked correctly.The rse made several attempts to follow up with the resolution of the case; however, they were unable to be reached.Based on the information available in the case and provided by the philips rse, the cause of the reported problem was not confirmed due to the customer's unresponsiveness.Based on the information available and results of additional analysis, no further action is necessary at this time.H3 other text : no response from customer.

Manufacturer Narrative

A philips remote service engineer (rse) remotely interviewed the customer who was onsite.The customer troubleshooted the device and the nbp kept pumping and reached high intervals.The customer cleared the reports and the nbp worked correctly.The philips fields support engineer (fse) went onsite to further evaluate the unit.The fse discovered the root cause of the issue was due the operator not clearing the settings.After the fse put the unit into stand by, the settings cleared, and the issue was resolved.The device has been tested multiple times and has since been in continuous use and is working fine.The fse followed up with the patient condition and it was revealed the blood pressure cuff did pinch the arm of a patient and per the customer there was a bruise.The patient did not seek medical attention.No pictures were available.The patient has since then recovered from the event.No further action is required 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 ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18933734
• MDR Text Key: 338030094
• Report Number: 9610816-2024-00157
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• 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?: Yes
• 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: 03/06/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/18/2024; 04/11/2024
• Supplement Dates FDA Received: 04/09/2024; 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female