MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX100

Model Number 867033

Device Problems Device Alarm System (1012); Protective Measures Problem (3015)

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

Event Date 11/01/2023

Event Type  malfunction  

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 the system alarm was not going off.It is unknown if the device was in use at the time of the event, and there was no adverse event reported.

Manufacturer Narrative

Several good faith efforts (gfe's) were sent by philips requesting additional information; however to date, no additional information was received.A philips remote service technician (rst) indicated there was no information about the case.The rst tried reaching out to the customer (biomed) who was onsite, but the customer did not call back and he could not be reached.The biomed mentioned he was going onsite to find out whether or not there was a problem; however, he never called back.Several gfes were sent by philips requesting additional information; however to date, no additional information was received.No further investigation or action is warranted at this time.H3 other text : customer did not answer the key market.

Event Description

The customer reported that the system alarm was not going off.The device was not in use monitoring a patient at the time of the event, and there was no adverse event reported.

• Brand Name: INTELLIVUE MX100
• Type of Device: INTELLIVUE MX100
• 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: 18215999
• MDR Text Key: 329116912
• Report Number: 9610816-2023-00627
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082595
• UDI-Public: 00884838082595
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 867033
• Device Catalogue Number: 867033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2023
• 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