MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PATIENT MONITOR

Model Number M8007A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bradycardia (1751)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that in the nicu unit on bed 23b the (b)(6) 2019 around 16:50, the patient monitor failed to announce, or announced too shortly an extreme bradycardia.The patient outcome is unknown, but it was stated that a pronounced patient stimulation was provided.

Manufacturer Narrative

H3 and h6: a philips modality sales specialist obtained the audit log from the central station and the trend report from the intellivue mp70 patient monitor for the time period in question.These were forwarded to philips product support engineering (pse) for further analysis.During the investigation, it was found that three red bradycardia alarms were announced at 16:55, 16:57, and 16:59.Additionally, two yellow heart rate low alarms were generated at 16:56 and 16:59.All alarms were acknowledged by the clinical staff.It was found that the setting for visual and audible alarm latching was set to "off", which resulted in red alarms only sounding briefly.If the alarm situation only lasts for a short period of time, the alarm will stop when the vitals have improved.To prevent this from happening, the alarms should be set to latching which requires the clinical staff to acknowledge the alarm to stop it from being announced.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: MP70 INTELLIVUE PATIENT MONITOR
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9473761
• MDR Text Key: 176950925
• Report Number: 9610816-2019-00333
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention