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

Model Number 865240

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burn(s) (1757)

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

Reporter phone # (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 burn-type injuries in pediatric patients who are being monitored within the pediatric intensive care unit (icu).The lesion is seen on the electrodes of the ecg leads.The nurse reports different levels of reaction in children's skin, ranging from mild irritation to skin detachment.They have currently tried different electrodes, and they all generate some type of injury.A resonance electrode was used, which does not have metallic elements that can transmit current, and the lesion was presented in the same way.They are performing electrode rotation every 4-6 hours to reduce the level of lesions.Electrical safety tests are carried out, with emphasis on current leakage to the applied part or patient, the following values: housing or chassis leakage test in normal condition: 0.1 ua.Housing or chassis leakage test in single fault condition: 107 ua.Leakage test patient in normal condition: 0.9 ua.Patient leakage test in single fault condition:1.9 ua.

Manufacturer Narrative

The customer was unable to provide any information about the third-party accessories.No further information regarding the event has been received at this time and it appears the event was unrelated to a philips device.The likely cause of the event is a strong allergic irritation of the patient¿s skin from the electrodes gel on the third-party lead set.Section d catalog number and serial number were changed back to the monitor information reported in the initial report.In the follow-up report these fields were updated to unknown for the lead sets.

Manufacturer Narrative

A philips product support engineer (pse) reviewed the available information.From a technical point of view, combustion can be ruled out.The leads off detection current is, depending on the hardware, about max.60 na dc per electrode.For the right leg drive in case of using the 12-lead ecg max.540 na.The respiration current is about max.390 a rms @ 40 khz.These are all within the safety limits and do not cause burned skin.Even in the event of a fault, no more than 50 a could flow, and burns are thus impossible.Furthermore, the safety test results indicate all values are well below their limit, so all tests passed.From a technical point of view, it can be excluded that the alleged burns have been caused by the monitor.However, burns may occur in case of using normal ecg-cables instead of orange or-cables during esu.Only the or cable contains a rl-impedance limiting the current.This is also documented in the instructions for use (ifu).Since there is no surgery stated in the description, one could assume strong allergic irritation of the patient¿s skin on the electrodes gel.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.Additional information was received which indicated the facility was using disposable third-party lead sets.Additional information was requested in regard to the third-party accessories.A final report will be submitted once the investigation is complete.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16681146
• MDR Text Key: 312681318
• Report Number: 9610816-2023-00152
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,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: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 05/04/2023; 06/08/2023
• Supplement Dates FDA Received: 06/01/2023; 07/03/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention