MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC M3154 LARGE DATABASE SERVER REL L.0

Model Number 865144

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2021

Event Type  malfunction  

Event Description

The customer reported that the speaker would stop providing audible alarms.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• Brand Name: M3154 LARGE DATABASE SERVER REL L.0
• Type of Device: M3154 LARGE DATABASE SERVER REL L.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 ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 11416428
• MDR Text Key: 234921864
• Report Number: 1218950-2021-10076
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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: 865144
• Device Catalogue Number: 865144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/16/2021
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2010
• 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