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

Model Number 863380

Device Problem Sparking (2595)

Patient Problem Numbness (2415)

Event Date 12/16/2023

Event Type  malfunction  

Event Description

The customer reported that the nurse was "zapped".This was clarified to indicate the pinky finger was numb, stinging and tingling.Subsequent information was received that indicated that while the user was unplugging the device, the facility outlet exploded sending sparks out in all directions a couple of feet out.The device was not in use on a patient at the time of the event.There was no adverse event reported.

Manufacturer Narrative

The visual inspection found from the submitted pictures from the customer confirmed the customer's issue of the device facility plugs having soot on the cover.A philips biomedical equipment services technician (bes) spoke with the customer onsite to evaluate the device in question.The reported problem was confirmed.The customer believed that the device had no issue, but the facility plugs' metal plate was a little loose and had screws missing.The customer confirmed with the philips biomedical equipment services technician (bes) that there were no adverse effects to the user after the event.No treatment was required.The facility plug outlet has been replaced to mitigate the issue.Reporting address state: on reporting institution phone #: (b)(6), reporter phone# (b)(6).

• 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: 18761591
• MDR Text Key: 336022961
• Report Number: 9610816-2024-00096
• Device Sequence Number: 1
• Product Code: DSJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

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
• Initial Date Manufacturer Received: 12/16/2023
• Initial Date FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2020
• 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