MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PIIC IX HARDWARE; CENTRAL STATION MONITOR

Model Number 866424

Device Problems Nonstandard Device (1420); Loss of Power (1475); Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Phone number (b)(6).

Event Description

The customer reported reboot/device shutdown/restart occurring in association with discharge actions at the information center ix.The issue occurred after (b)(6) 2018.There was no patient incident.

• Brand Name: PIIC IX HARDWARE
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7270357
• MDR Text Key: 100137252
• Report Number: 1218950-2018-01765
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/24/2018

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: 866424
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2017
• 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