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 Problems Death (1802); Dyspnea (1816); Loss Of Pulse (2562)

Event Date 05/11/2016

Event Type  Death  

Manufacturer Narrative

There was no malfunction of the device.A review of the provided alarm logs found that the monitor had alarmed, during the time of the reported event, and had been silenced.A philips field service engineer (fse) went on site, and found the device to be in use (it has been used on other patients, since the initial report) and working properly.The fse was able to verify operation of the monitor where red and yellow alarms were simulated and both visual and audible alarms were verified.The device remains at the customer site, and no subsequent calls have been logged for this device.No further investigation is warranted at this time.

Event Description

The customer reported that the system was not alarming.Further information received stated that on (b)(6) 2016, the rn went into room 4.412 on 4 south to deliver care at 15:36.At this time, the rn noted the patient not breathing; on assessment patient noted to have no pulse.Cardiac arrest called, immediately started acls, and team arrived to help.The patient died.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 5694133
• MDR Text Key: 46363068
• Report Number: 9610816-2016-00150
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021300
• 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
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2010
• 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