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

Model Number 866117

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Death (1802); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969)

Event Date 07/11/2017

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.Patient information has been requested.

Event Description

The customer reported that a patient had changes in the ecg st segment that were not initially detected by st alarms on the monitoring system for a telemetry patient.The customer indicated that staff received delayed notification of a change in the patient condition as a result of this issue therefore the device is considered to have possibly been a factor in this event.The patient experience chest pain and was taken to the cath lab for an evolving myocardial infarction (heart attack) but died the next day.

Manufacturer Narrative

The customer received detailed information from the clinical specialist in the solutions center regarding the fact that once the st values had exceeded the limits alarms were provided and if st could not be measured due to st distortion from the number of pvcs occurring then the st value would be "?".The customer described that they understood the findings and had no further questions.The device remains in use.No malfunction occurred.The customer received st segment alarms when the st alarm limits had been violated by more than 2 mm in accordance with set alarm limits.When the patient was having ventricular ectopy with multiform and pair pvc events, the st segment could not be measured as evidenced by the "?" for measurements.The evolution of st segment changes in the inferior leads would not be immediately detected since the customer had not selected these leads for continuous monitoring/st analysis.However, st segment alarms were documented in the clinical audit logs several times between (b)(6) on the evening in question.The customer has already received information about the investigation of this issue and has no further questions.

• Brand Name: PIIC IX UPGRADE FROM PIIC
• 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: 6791429
• MDR Text Key: 82593665
• Report Number: 1218950-2017-05630
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: 866117
• Device Lot Number: 00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/14/2017
• Supplement Dates Manufacturer Received: 07/21/2017
• Supplement Dates FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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
• Patient Outcome(s): Death