MAUDE Adverse Event Report: GE APEX FH TRANSMITTER

Device Problem Device Alarm System (1012)

Patient Problem Cardiac Arrest (1762)

Event Date 07/18/2016

Event Type  malfunction  

Event Description

Asking for an ek-pro algorithm review, because it took the system 9 seconds to alarm asystole after the last qrs beat.There was a 3 second pause arrhythmia preceding the last qrs beat.Using the 1500 method that pause would equal a hr of 20 bpm.If you take into account this 3 second pause right before the last qrs beat, it took the system 12 seconds to alarm asystole.Cscs s/n is (b)(4), b450 s/n is (b)(4), fh transmitter s/n is (b)(4).

• Brand Name: APEX FH TRANSMITTER
• Type of Device: APEX FH TRANSMITTER
• Manufacturer (Section D): GE
• MDR Report Key: 5917224
• MDR Text Key: 53784734
• Report Number: MW5064439
• Device Sequence Number: 2
• Product Code: DXH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR