MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70

Model Number 862451

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2021

Event Type  malfunction  

Event Description

The customer called philips to report that, on (b)(6) 2021, the mp70 monitor labeled 2067 did not alarm for a patient¿s desaturation event after the initial alarm.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: derek sammarco ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11572060
• MDR Text Key: 242728067
• Report Number: 9610816-2021-10043
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/27/2021
• Date Manufacturer Received: 02/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2006
• 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