MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PIC IX HARDWARE

Model Number 866424

Device Problem Device Alarm System (1012)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that their central station was emitting yellow alarms when the alarm should have been red.The alarm discrepancy resulted in one patient needing to be intubated.

Manufacturer Narrative

Do to incorrect product and registration number a new report has been generated.Please refer to 9610816-2021-10257 for complete report.

• Brand Name: PIC IX HARDWARE
• Type of Device: PIC IX HARDWARE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11798227
• MDR Text Key: 249725692
• Report Number: 1218950-2021-10518
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866424
• Device Catalogue Number: 866424
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/07/2021
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention