MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240 (MX800)

Device Problem Alarm Not Visible (1022)

Patient Problem Blood Loss (2597)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer's biomed reported that there was "no alarm for art line disconnect between 9 -10 am today, room 4071, 4e icu¿.The patient lost 200 cc blood after removing the invasive blood pressure catheter.

Manufacturer Narrative

The reported problem was investigated via field service engineer (fse).The customer stated that the monitor did not alarm an arterial line disconnect and the patient exsanguinated about 200cc of blood.The customer stated that the event took place on (b)(6) 2019 between 9-10 am at room 4071, 4e at the icu.A fse went onsite to provide the logs / trend data to the product support specialist (pse) and r&d for evaluation.The remote support checked the clinical audit trail and confirmed no pressure disconnect alarm at the device.The remote support advised the customer to enable the pressure extreme alarm limits and changed the alarms configuration to systolic, diastolic and mean pressure.It has been established that there was no product malfunction.During investigation it could be identified that the alarm condition of non-pulsatile pressure and continuously pressure less than 10mmhg was not present.The remote support advised the customer to enable extreme alarm limits and changes alarm configuration.The monitor worked as intended and there was no malfunction of the device.This issue was caused by user error and the alarm configuration.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 8873374
• MDR Text Key: 153653805
• Report Number: 9610816-2019-00208
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K102562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

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 (MX800)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention