MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP70 INTELLIVUE PT MONITOR; PT MONITOR WITH PORTAL TECHNOLOGY

Model Number M8007A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Tachycardia (2095)

Event Type  malfunction  

Event Description

The customer reported that they noticed that the heart rate of the pt was around 220 and the hr high was set at 200.No pt harm was reported.

Manufacturer Narrative

(b)(4).A follow up report will be submitted upon completion of the investigation.

• Brand Name: MP70 INTELLIVUE PT MONITOR
• Type of Device: PT MONITOR WITH PORTAL TECHNOLOGY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 7103 4; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minuteman rd; andover, MA 01810 ; 9786597844
• MDR Report Key: 4357127
• MDR Text Key: 5235484
• Report Number: 9610816-2014-00321
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8007A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: No
• 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