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

Model Number 862451

Device Problem Patient Data Problem (3197)

Patient Problems Tachycardia (2095); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  Injury  

Event Description

The customer called philips to report that they could not find retrospective data for a patient, monitored by an mp70 bedside monitor, on their piicix alarm audit logs and patient history.The device was reported to be in use on a patient.The patient did encounter several cases of supraventricular tachycardia (svt), but made a full recovery following those svts.

• 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: 12144039
• MDR Text Key: 260779502
• Report Number: 9610816-2021-10212
• 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: 07/09/2021
• Is this an Adverse Event Report?: Yes
• 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: 06/16/2021
• Date Manufacturer Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2008
• 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
• Patient Outcome(s): Hospitalization