MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX500 PATIENT MONITOR

Model Number 866064

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 05/25/2023

Event Type  Injury  

Event Description

The customer reported an unspecified patient safety incident.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

Philips received a complaint on the iintellivue mx500 patient monitor indicating that "initially, the customer called needing assistance w/picix audit log entries.However, after further discussion reported a patient safety incident in rm #743, w/mp500 sn #(b)(6) /rev n.0, on 7 south.".

Manufacturer Narrative

A philips field service engineer (fse) remotely changed the alarm settings to enhance text for the unit (7 south).A good faith effort (gfe) sent confirmed the following: 1, the event timeframe: 17 may 2023 time: 00:00 until 12:06 -unit: 7s room 743 (the patient was transferred to mi06 at/around 12:06) 2- the customer was asking for assistance to understand what triggered the alarm.It was indicated on the call the patient did expire but was not able to provide any additional information.3- the hospital snr manager, risk manager (hrm) stated they initially thought there might be an issue; however, upon investigating the event and conducting a root cause analysis (rca), it was determined there was no issues with the products/solution.No additional support or assistance is needed from philips.The hrm authorized to proceed and close the case based upon their findings/determination.She stated that they found some specific needs/requirements for when staff is operating from different clinical units but didn't provide details on these requirements.4.The hrm confirmed that the hospital does not see a connection between the philips product and the occurred death, as they are looking to workflow and processes as the root cause of the event.Results of functional testing and communications indicate that the adverse event mentioned in this complaint has no allegation of a philips product malfunction.Based on the information available and the testing conducted, the reported problem has the hospital's workflow and processes as the root cause of the event.The engineer provided their analysis findings, updating alarm settings for text enhancement on the picix.There is supporting evidence this adverse event was unrelated to a philips device.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Based on the information available and results of additional analysis, no further action is necessary at this time.

• Brand Name: INTELLIVUE MX500 PATIENT MONITOR
• Type of Device: INTELLIVUE MX500 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 17181328
• MDR Text Key: 317643316
• Report Number: 9610816-2023-00297
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038776
• UDI-Public: 00884838038776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 866064
• Device Catalogue Number: 866064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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; Death