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

Model Number M8007A

Device Problem Device Alarm System (1012)

Patient Problems High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 04/02/2014

Event Type  Injury  

Event Description

The customer reported that the arterial blood pressure of the pt fell down to 24 and the user did not notice any alarm on the monitor or the iic.A few minutes later, there was a tachycardia alarm and the pt had to be resuscitated.Resuscitation was successful.

Manufacturer Narrative

(b)(4).A follow up report will be submitted after philips obtains more information concerning this event.

• Brand Name: MP70 INTELLIVUE PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICLA SYSTEMS; hewlett - packard str. 2; boeblingen 7103 4; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786597844
• MDR Report Key: 3763300
• MDR Text Key: 4465112
• Report Number: 9610816-2014-00094
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K021300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2006
• 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