MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3

Model Number 867030

Device Problem Unintended Electrical Shock (4018)

Patient Problem Shock (2072)

Event Date 11/08/2023

Event Type  Injury  

Event Description

The customer reported when the nurse attempted to un-dock the x3 from the monitor, the nurse felt an electric shock in their arm that was holding the handle.The nurse went to the emergency department for evaluation.The device was not in use on patient at time of event, there was no patient adverse event reported.There was an adverse event reported on a nurse.

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.    e1: reporter institution phone number: (b)(6).E1: reporter phone number: (b)(6).

Manufacturer Narrative

Philips received a complaint on the intellivue x3 indicating that when the ward nurse tried to disconnect the x3 module from the mx550 monitor, the nurse was electrified at the handle on the arm holding the module handle, and subsequently ended up in the emergency department.It was provided that the nurse returned to work with an electrical shock mark on her arm, but there is insufficient information at this time to determine whether the event meets criteria for serious injury.The following functional tests were performed: the device was sent to bench repair.A bench repair technician (brt) evaluated the device and did not find any defects.An extended evaluation of both the mx550 and the x3, separately and used together, were done, and the brt found no issues with the devices in normal use.Both devices passed all tests including safety tests.Based on the information available and the testing conducted philips was unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE X3
• Type of Device: INTELLIVUE X3
• 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: 18277510
• MDR Text Key: 329860091
• Report Number: 9610816-2023-00646
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 867030
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• 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
• Patient Outcome(s): Required Intervention