MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240

Device Problems Patient-Device Incompatibility (2682); Excessive Heating (4030)

Patient Problem Localized Skin Lesion (4542)

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).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 burn-type injuries were seen in pediatric patients who were being monitored in the pediatric icu.The lesion was seen on the electrodes of the ecg lead set.It is unknown which type of ecg lead set the customer was using.The device was in use at the time of the reported event.The patient sustained a burn-type injury.

Manufacturer Narrative

The customer performed electrical safety tests with emphasis on current leakage to the applied part or patient.The customer indicated they perform electrode rotation every 4-6 hours.Additional information regarding the event and the product were requested, but the customer declined to provide additional information per the device distributor.A good faith effort confirmed the customer was not using a philips lead sets device, but a third-party lead set, already been disposed.Further details regarding manufacturer name and product specifications of the ecg accessories were asked but remain unknown.A philips product support engineer (pse) no device issue was identified following the review of the available information.The likely root cause of the patient¿s injuries is allergic irritation.The complaint was escalated for technical investigation and the results indicate a review of the available information concluded the likely cause of the patient¿s injuries is allergic irritation to the electrodes gel.The cause of the reported problem is likely allergic irritation to the electrodes gel.The reported problem was not confirmed since we have confirmation that the customer was using a third-party non-philips device.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 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: 16690623
• MDR Text Key: 312789969
• Report Number: 9610816-2023-00159
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2020
• 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