MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC M3150 UPGRADE REL N.0

Model Number 865423

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

The customer reported that a bradycardia occurred, but the central station did not alarm.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• Brand Name: M3150 UPGRADE REL N.0
• Type of Device: M3150 UPGRADE REL N.0
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11380591
• MDR Text Key: 233748423
• Report Number: 1218950-2021-10026
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: 865423
• Device Catalogue Number: 865423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/12/2021
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 02/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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