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

Model Number 865423

Device Problem No Audible Alarm (1019)

Patient Problem Ventricular Fibrillation (2130)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that alarm issues with their patient information center were occurring and the patient went into ventricular fibrillation.

Event Description

The customer reported that on (b)(6), 2021 at 13:35 pm a patient went into ventricular fibrillation and the central station failed to audibly alarm.

Manufacturer Narrative

A philips field service engineer (fse) went onsite to pull the audit logs from the event and test the equipment in question.The fse tested both yellow and red alarms and confirmed that no hardware issues were occurring with the customers system.The audit logs were then provided to a philips clinical product specialist (cps).The cps noted that the audit log state that the system alarmed at 13:35 and that the system emitted a red alarm tone which was subsequently silenced by the user.There was no malfunction of a philips device; the fse and cps confirmed that the systems hardware and software were both functional during the cardiac event.The customer will be informed of the cps's findings which will resolve the issue.The device remains onsite and in use.

• 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 st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12631606
• MDR Text Key: 276366506
• Report Number: 1218950-2021-11023
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• 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?: Yes
• 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
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2012
• 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): Required Intervention