MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC M3150 UPGRADE REL N.01

Model Number 866099

Device Problem False Alarm (1013)

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

Event Date 06/25/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported a single episode going back to about (b)(6) 2021.At bed 1, a red asystole alarm went off without any action by the operator.The device was in use on a patient.There was no report of patient or user harm.

Event Description

The customer reported a single episode going back to about (b)(6) 2021.At bed 1, a red asystole alarm went off without any action by the operator.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: M3150 UPGRADE REL N.01
• Type of Device: M3150 UPGRADE REL N.01
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 12413901
• MDR Text Key: 269589108
• Report Number: 1218950-2021-10885
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup

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: 866099
• Device Catalogue Number: 866099
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/20/2021
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/02/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1