MAUDE Adverse Event Report: SPACELABS SPACELABS CLINICAL ACCESS/ ICS; CLINICAL EVENT INTERFACE

Device Problems False Device Output (1226); Device Operates Differently Than Expected (2913)

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

Event Date 07/28/2017

Event Type  malfunction  

Event Description

On a recently cardiac monitored patient's ecg record, the saved cardiac event time stamps did not match time stamps on overall strip review analysis.This is a known issue according to spacelabs when certain editing steps are taken in the software, yet the software does not prevent a user from taking the very steps which spacelabs tech support says should never be taken.Very serious documentation integrity issue that needs to be corrected by the manufacturer asap.

• Brand Name: SPACELABS CLINICAL ACCESS/ ICS
• Type of Device: CLINICAL EVENT INTERFACE
• Manufacturer (Section D): SPACELABS
• MDR Report Key: 6791517
• MDR Text Key: 82694256
• Report Number: MW5071544
• Device Sequence Number: 1
• Product Code: MSX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other