MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX40 802.11A/B/G; PATIENT MONITOR

Model Number 865352

Device Problem Insufficient Information (3190)

Patient Problem Burn, Thermal (2530)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Date of incident unknown at time of report.(b)(4).

Event Description

The customer reported that the mx40 electrode caused a burn on a patient.A medwatch was generated.The patient stated that he felt a sudden burn on the left upper chest skin and the telemetry electrode was immediately removed.A new wound was present where the electrode was.The telemetry box including the battery and leads were sequestered and sent to the biomed.The biomed contacted phillips for evaluation.The electrodes were not saved.Until further information is known the issue will be considered as a serious injury and reported.

Manufacturer Narrative

Per the nurse manager the "wound" was described as circular and approximately 2 cm by 2 cm with a bright red appearance.The "wound" was treated with ointment and gauze dressing.The nurse manager stated that the "wound" was in only one location on the patient on the left upper chest area.Per the patients nurse rn the electrode had been changed 2-3 times during the nurse shift because the patient was sweaty and the electrode kept falling off.Per the patient's nurse the staff changes the electrodes when the patient showers or they are falling off.The patient had been monitored continuously for 11 days and had fragile skin that was easily irritated.The electrode being used was covidien/kendall 935 foam electrodes, product #22935 and not a philips electrode.The mx40 was returned to the repair bench where the bench technician tested the internal current on the mx40 device and had found that the device was drawing normal current values and was not overheating.Per the mx40 telemetry product support engineer (pse), the mx40 does not generate or deliver current via the lead set that would cause injury to the patient.Per the pse, the issue may be related to the fragility/sensitivity of the patient¿s skin.Since the customer was not using philips electrodes and was using covidien electrodes, the issue was reported to covidien on (b)(6) 2018 along with all medwatch information.It is considered that covidien will provide further information to the fda concerning the issue.Based on the information available, there is no data to support that the mx40 or other philips product caused or contributed to the patient issue and the philips investigation is considered as closed.Further information to be provided by covidien concerning the covidien electrodes being used on the patient where the red skin irritation was observed.This issue will not be considered as a serious injury based on the information that it was a red skin area treated with ointment and gauze and likely a skin irritation.

• Brand Name: INTELLIVUE MX40 802.11A/B/G
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7718131
• MDR Text Key: 114962150
• Report Number: 1218950-2018-05916
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: (01)00884838030350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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: 865352
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 06/26/2018
• Supplement Dates FDA Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2018
• 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: 43 YR