MAUDE Adverse Event Report: GE HEALTHCARE CLINICAL INFORMATION CENTER; DETECTOR AND ALARM, ARRHYTHMIA

Device Problems Device Alarm System (1012); Self-Activation or Keying (1557)

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

Event Type  malfunction  

Event Description

The customer reported the device arrythmia pause alarm changed from crisis to warning without user interaction.There was no reported patient injury associated wtih this event.

Manufacturer Narrative

Patient data not currently available.Reporter's occupation is unknown a follow-up report will be submitted when the investigation is complete.

Manufacturer Narrative

The scope of this investigation is based upon the log files supplied and information obtained from the field engineer (fe) about this specific issue.The (b)(6) 2014 logs for tele|cic3 were reviewed.The pause alarm level was set at advisory for all telemetry beds in the tele care unit asserting that alarm between (b)(6).There was no evidence of the pause alarm default level changing from crisis to warning as alleged by the customer.In addition, there was no indication of the user changing the level for this alarm on those days.The available information indicates that the pause alarm default level for telemetry beds in the tele care unit did not change from crisis to warning during the time period in question.The system was operating as designed.

• Brand Name: CLINICAL INFORMATION CENTER
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): GE HEALTHCARE; 8200 w. tower ave.; milwaukee, wi 53223
• Manufacturer (Section G): GE HEALTHCARE; 8200 w. tower ave.; milwaukee, wi 53223
• Manufacturer Contact: deb lahr ; 540 w. northwest hwy; barrington, IL 60010 ; 8472774472
• MDR Report Key: 4240907
• MDR Text Key: 4987655
• Report Number: 2124823-2014-00023
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• 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?: No
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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