MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX400 PATIENT MONITOR

Model Number 866060

Device Problems Device Alarm System (1012); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2022

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

It was reported that a patient received a blister from ecg leads.It was not conveyed how severe the patient harm was or if any medical intervention was required.

Manufacturer Narrative

The customer reached out to philips via a national medical products administration report (nmpa # (b)(4)) requesting an investigation of this issue.Good faith effort (gfe) functional tests and communications were performed and confirmed the following: ¿ the allegation was made in the event a potentially serious injury was to occur, which did not happen.The post market surveillance (pms) personnel stated "type of harm = abnormal alarm, the nurse needs to deal with the alarm repeatedly.The customer claimed the malfunction could cause or contribute to harm or injury if it recurs." ¿ an ecg strips of the (b)(6), or mms for analysis were not available, and it is not known whether an ecg analysis was performed.¿ a technical investigation was requested and performed by the product engineer (pe).He stated: "in order to assess these false positive alarms, we would need to review the ecg waveform at the time of these events.With the information that is currently available to me, the most likely technical explanation is either the ecg amplitude was below the threshold to be detected, or fusion/pseudo fusion beats from a pacemaker (no indications in the incident form that the patient had a pacemaker) and therefore the asystole alarms were announced false positively.This complaint is related to alarm fatigue; the product risk assessment considers product-related failures to alarm which seems not the case here.¿ results of the clinical assessment performed by a pms clinical expert based on the information available states "upon review of the information, there was no injury or death noted within the complaint record in relation to the alarm error reported." based on the information available and the testing conducted, the cause of the reported problem can¿t be identified with the information available; however, the reported problem was confirmed to possess the potential to happen as predicted by the safety risk assessment (sra).The engineer provided their analysis findings.The investigation concludes that no further action is required at this time.

Event Description

Philips has received a complaint on the intellivue mx400 patient monitor presenting an "abnormal alarm, the nurse needs to deal with the alarm repeatedly.The customer claimed the malfunction could cause or contribute to harm or injury if it recurs" the device was in clinical use during the event and no death, serious injury or adverse event was reported to have occurred or was alleged as a result of this issue.

• Brand Name: INTELLIVUE MX400 PATIENT MONITOR
• Type of Device: INTELLIVUE MX400 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 15718453
• MDR Text Key: 302917980
• Report Number: 9610816-2022-00557
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838038752
• UDI-Public: 00884838038752
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K130849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• 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: 866060
• Device Catalogue Number: 866060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/02/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 04/03/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Female