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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/24/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported a patient incident on (b)(6) 2019, where a patient required intervention but was stabilized and discharged since that date.The customer reports that the monitor operation is not in question, but wanted to understand how alarms can be turned off and requested alarm review for that such time period.

Manufacturer Narrative

H3 and h6: the clinical application specialist (cas) called the customer biomed back and the biomed stated that he needed assistance in determining if alarms were turned off and how they can be turned off.The biomed confirmed that the intellivue mp70 operation is not in question.Further details of what occurred were not available.The cas explained the customer biomed how silencing and pausing alarms works and how each parameter can be turned off dependent on configuration.Despite multiple attempts to obtain additional information regarding the patients intervention for the patient, this information was not provided by the customer.This issue was resolved by instructing the customer.The device worked as intended and there was no malfunction of the device.The device remains at the customer site, and there have been no subsequent calls logged for this device/issue.No further investigation or actions are warranted at this time.No parts were replaced.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: 8439509
• MDR Text Key: 139428066
• Report Number: 9610816-2019-00080
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

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: M8007A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/21/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention