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

Model Number 866424

Device Problem Device Alarm System (1012)

Patient Problems Fall (1848); Tachycardia (2095); Dizziness (2194)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported the pic ix was monitoring a patient on telemetry 12 bed 3e_23, whose heart rate alarms were set between 50-120 beats per minute (bpm).When the patient walked to the bathroom, their heart rate increased to 190 bpm and the patient became dizzy and fell.The customer indicated the pic ix failed to alarm.The serious injury is being reported with mdr# 1218950-2019-06445.

• 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: 8993121
• MDR Text Key: 159979046
• Report Number: 1218950-2019-06948
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838052130
• UDI-Public: (01)00884838052130
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2018
• 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