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

Model Number 866424

Device Problem Insufficient Information (3190)

Patient Problem Asystole (4442)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the doctor wanted to print out an entire course of events from a patient that had an asystole in ward 7, however, the printer only printed out 1 page and only what was visible on the screen.

Event Description

It was reported that the doctor wanted to print out an entire course of events from a patient that had an asystole in ward 7, however, the printer only printed out 1 page and only what was visible on the screen.

• 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: 12445510
• MDR Text Key: 270481617
• Report Number: 1218950-2021-10901
• 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: 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?: 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: 08/30/2021
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention