MAUDE Adverse Event Report: SPACELABS HEALTHCARE LTD. SYSTEM CARDIOLOGY INFORMATION SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMABLE

Model Number 98200

Device Problems Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has initiated an investigation into this matter.A supplemental report will be filed once the investigation is complete.

Event Description

A hospital has voiced concern that when upgrading from v9 to v11, all the 12 leads tests on which the costumer had previously deleted the automatic interpretation (coming from cardioexpress devices and/or cd12 usb) were again populated with the glasgow interpretation.This has caused some issues due to incorrect interpretations which were thought to be from a physician.No injury to patient reported.

Manufacturer Narrative

The reported issue has been identified as a software problem.Spacelabs has initiated a field corrective action and notified the office of medical device and radiological health operations, division 3 of this action on november 6th, 2020.The fda has not yet assigned a recall number z-0562-2021.We also began notifying customers of this activity with a letter dated november 6th, 2020.This investigation is considered complete and this particular issue closed.H3 other text : placeholder.

• Brand Name: SYSTEM CARDIOLOGY INFORMATION SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMABLE
• Manufacturer (Section D): SPACELABS HEALTHCARE LTD.; unit b, foxholes centre; john tate road; hertford SG137 DT; UK SG137DT
• MDR Report Key: 10766480
• MDR Text Key: 249619810
• Report Number: 9611295-2020-00003
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): Y
• PMA/PMN Number: K152881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/12/2021

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: 98200
• Device Catalogue Number: 98200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1