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 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that vs30 monitor mounting plates are bending causing damage to vhm arm base and monitors are falling off the vhm arms.The device was in use on a patient.There was no report of patient or user harm.

Event Description

The customer reported that vs30 monitor mounting plates are bending.This is causing damage to vhm arm base and monitors are falling off the vhm arms.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

Philips field service engineer contacted the supplier of the mount which is gcx and provided them with pictures of the mounts from the customer.Gcx investigated the reported problem, and it was identified that excessive force was likely used to manipulate the monitor on the arm, leading to the breakage.Based on the pictures provided by the customer, the monitors were mounted over the center of patient beds which the gcx investigation believes causes users to extend their reach and perhaps apply excessive pressure to manipulate the monitor on the arm.The gcx wall channel installation guide clearly specifies instructions and warnings for proper installation to reduce risk.Information provided shows that the related installations did not comply with the stated instructions and warnings.Philips recommended that the wall channels be installed in a more customary location on the headwall that is to the side of the bed.This would help the user to not apply excessive force when tilting the monitor.

Manufacturer Narrative

This supplemental report is submitted with reference to manufacturers report 9610816-2021-10147 to update manufacturing site.

Event Description

The customer reported that vs30 monitor mounting plates are bending.This is causing damage to vhm arm base and monitors are falling off the vhm arms.The device was in use on a patient.There was no report of patient or user harm.

• 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 11900497
• MDR Text Key: 253140209
• Report Number: 9610816-2021-10147
• 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: 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: 863380
• Device Catalogue Number: 863380
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/05/2021
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 05/05/2021; 05/05/2021
• Supplement Dates FDA Received: 11/04/2021; 01/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1