MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLISPACE ECG SOFTWARE; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number 860426

Device Problem Loss of Data (2903)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Follow up report will be submitted once the investigation is complete.

Event Description

The customer was migrating some confirmed ecgs from their tracemastervue to the iecg during an upgrade and found that the algorithm version had changed.This means that the interpretation that the doctor had edited and approved was lost and a computer interpretation that was not reviewed was put in its place.There was no report of patient harm or injury in this case.

Event Description

Customer reported that previously stored ecg, prior to golive was retrieved for comparison.It was noted that the analysis of the stored ecg in epic was different from analysis presented at iecg of the retrieved ecg.It appeared that the ecg in iecg rendered was reanalyzed using 0c algorithm.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.

• Brand Name: INTELLISPACE ECG SOFTWARE
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: richa shah ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6335482
• MDR Text Key: 67880176
• Report Number: 1218950-2017-01023
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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