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

Model Number 866027

Device Problems Failure to Discharge (1169); Nonstandard Device (1420); Inappropriate or Unexpected Reset (2959)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted more than 30 days after the become aware date due to a retrospective review under capa (b)(4).

Event Description

The customer reported experiencing 2018 reboot issues associated with admit/discharge actions at the information center ix.The device was not in use on a patient.

• Brand Name: PIIC IX HARDWARE UPGRADE
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8960652
• MDR Text Key: 156724322
• Report Number: 1218950-2019-06776
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/03/2018

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: Other
• Device Model Number: 866027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 09/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0776-2018
• Patient Sequence Number: 1