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

Model Number	867033
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported that the mx100 did not trigger an alarm during monitoring loss.It is unknown if the device was in use at time of event, and there was no adverse event reported.
Additional Manufacturer Narrative
The remote service engineer (rse) spoke to the customer and confirmed that the problem was that the mx100 was connected via the intellivue instrument telemetry (iit) after the log-out from the network (leaving the ward), it did not connect again.A field service engineer (fse) went onsite and found that the mx100 did not receive an ip address if it connected to the iit telemetry network/control center for approximately 2 minutes (e.G.Patient leaves the monitored area).The fse updated the software of the mx100 from n.00.04 to n.00.06 and p.01.02 also, but the problem was not solved.The fse advised on a work around: mx100 must be switched off once and then switched on again to resolve the connection issue.The complaint was then escalated for technical investigation and the results indicate an issue with the radio board.The fse replaced the radio board to the old version, which seemed to reduce the issue.The product support engineer (pse) has advised that the issue has been reproduced in the lab.A possible fix will be investigated, but timing of implementation and final release of a solution is unclear at this time.The cause of the reported problem was the radio board.The reported problem was confirmed.After replacing the radio board, the issue has been reduced.
Event or Problem Description
The customer reported that the mx100 did not trigger an alarm during monitoring loss.The device was in use at time of event, there was no adverse event reported.

• Brand Name: INTELLIVUE MX100
• Common Device Name: 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 ; 70314632031
• MDR Report Key: 17309308
• Report Number: 9610816-2023-00343
• Device Sequence Number: 20504281
• Product Code: MHX
• UDI-Device Identifier: 00884838082595
• UDI-Public: 00884838082595
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 867033
• Device Catalogue Number: 867033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 02/15/2024
• Date Device Manufactured: 11/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown