MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX700 PATIENT MONITOR

Model Number 865241

Device Problems Use of Incorrect Control/Treatment Settings (1126); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The customer reported that the pulse (spo2) vitals trend is missing.The surgeon lost track of the patient's pulse rate before and after an operation.It was reported the patient's life will be affected.After checking through the vitals trend, it was identified the pulse under spo2 was missing.A configuration setting was done to add the pulse (spo2) into the vitals trend.After completion of the configuration, the pulse is now being shown in the vitals trend.

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.Reporting institution phone # and reporter phone #: (b)(6).

Event Description

Problem statement: it was reported that patient spo2 vital trend was missing during a procedure.As the event was reportable to a regulatory authority and indicated a possible failure of a device, labeling, or packaging to meet any of its specifications, an investigation was required.Patient/user involvement : was the device being used on a patient at the time of the event, including for the purposes of diagnosis? the device was in clinical use on a patient at the time of the event.Was there any adverse event to the patient or user? if yes, describe? no adverse event occurred.If there was an adverse event, did the device cause or contribute to the adverse event, and how? no adverse event occurred.Complaint evaluation a philips field service engineer (fse) went to the customer site.The engineer was able to confirm the product was functioning as intended.The device configuration did not permit the spo2 vital trend to display.Customer resolution and conclusion the customers issues was resolved by performing a configuration change.After the configuration change the spo2 vital trend displayed on the device.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MX700 PATIENT MONITOR
• Type of Device: INTELLIVUE MX700 PATIENT 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15501042
• MDR Text Key: 300758897
• Report Number: 9610816-2022-00495
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029088
• UDI-Public: 00884838029088
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K150310
• 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

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865241
• Device Catalogue Number: 865241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2014
• 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): Other