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

Model Number 865240

Device Problem No Audible Alarm (1019)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2022

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

It was reported that the intellivue mx800 patient monitor did not alarm for the invasive blood pressure (ibp) on (b)(6) 2022.The device was in use monitoring a patient at the time of the reported event.A serious injury to the patient requiring intervention was reported.No further details regarding the event, any medical measures taken to assist the patient, and the patient, such as gender, age, height, and weight, had been made available at the time of this report.

Event Description

It was reported that the intellivue mx800 patient monitor did not alarm for the invasive blood pressure (ibp) on (b)(6) 2022.The device was in use monitoring a patient at the time of the reported event.A serious injury to the patient requiring intervention was reported.No further details regarding the event, any medical measures taken to assist the patient, and the patient, such as gender, age, height, and weight, were made available by the customer.The philips field service engineer (fse) confirmed the event.The fse went onsite and noted that the alarm was silenced at 9:24 am prior to the event, but could not confirm that it was audibly alarming at the time of the event.From 9:24am on (b)(6) 2022 to 10:18am, no abp data was shown on the "clinical audit trail".Output shows that the alarm was silenced at 9:24am.Neither pic ix logs nor bedside monitor logs show the status of the abp measurement during that time frame.There have been attempts made for additional information with no response.The cause of the event is unknown and it could not be established if the device contributed to the reported adverse event.The fse noted that the alarm was silenced by the user prior to the reported time frame.The device remains on site.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14856750
• MDR Text Key: 295032514
• Report Number: 9610816-2022-00352
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838020733
• UDI-Public: 00884838020733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,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: 865240
• Device Catalogue Number: 865240
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• 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): Required Intervention