MAUDE Adverse Event Report: PHILIPS MED SYSTEMS MP70 INTELLIVUE PT MONITOR

Model Number M8007A

Device Problem Insufficient Information (3190)

Patient Problem Electric Shock (2554)

Event Date 07/18/2014

Event Type  Injury  

Event Description

The customer stated that the pt received a shock from the spo2 probe.The probe will be removed from the device and will be picked up for evaluation.

Manufacturer Narrative

Pr#: (b)(4).A follow up report will be submitted after philips obtains more info concerning this event.

• Brand Name: MP70 INTELLIVUE PT MONITOR
• Manufacturer (Section D): PHILIPS MED SYSTEMS; hewlett-packard str.2; boeblingen 7103 4; GM 71034
• Manufacturer Contact: denyse murphy ; 3000 minuteman rd; andover, MA 01810 ; 9786597844
• MDR Report Key: 4017604
• MDR Text Key: 4876575
• Report Number: 9610816-2014-00197
• 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: 07/18/2014

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
• Initial Date Manufacturer Received: 07/18/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2007
• 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