MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. APEXPRO FH; MONITOR, PHYSIOLOGICAL, PATIENT (WIT

Model Number 2025064-004

Device Problems Defective Alarm (1014); Alarm Not Visible (1022)

Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

Udi not required legal manufacturer: (b)(4).Ge healthcare's investigation is on-going at this time.A follow-up report will be submitted when the investigation is complete.

Event Description

Per medwatch report (b)(4): the patient was off telemetry and it was reported that no alarms were provided.The patient coded while being off telemetry.

Manufacturer Narrative

Per medwatch report (b)(4), it was reported that on (b)(6) 2020 at around 17:22 a patient being monitored on the apexpro fh telemetry system coded and no alarms were provided.After the event, the attending doctor determined telemetry monitoring was lost approx.40 min.Prior to the event, however, the nursing staff stated they were not aware as they did not observe any alarms.The report also stated that during testing following the event, the telemetry transmitter exhibited issues with intermittent function but that the networked central station asserted a no telem alarm as expected and in accordance with product specifications.Ge healthcare (gehc) attempted to contact the customer's biomedical engineer and risk manager on multiple occasions.The biomed eng responded once but could not provide any further details regarding the patient's status.The customer did not reply to gehc requests for access to test the telemetry system's alarm function or download log files for gehc engineering analysis.As part of a service request and prior to gehc receiving the medwatch report, gehc depot repair received the affected telemetry transmitter and noted that the bulkhead and battery contacts were corroded.The transmitter was also missing the battery door and serial port plug.The necessary service was performed on the device and it was returned to the customer.Due to the limited information available, gehc was unable to determine the root cause for the alleged missed no telem alarm, however, lack of clinical staff awareness of the no telem alarm at the central station may be a possible cause.Gehc did not identify any adverse trend related to no telem alarm.H3 other text : per medwatch report (b)(4), it was reported that on (b)(6) 2020 at around 17:22 a patient being monitored on the apexpro fh telemetry system coded and no alarms were provided.After the event, the attending doctor determined telemetry monitoring was lost approx.40 min.Prior to the event, however, the nursing staff stated they were not aware as they did not observe any alarms.The report also stated that during testing following the event, the telemetry transmitter exhibited issues with intermittent function but that the networked central station asserted a no telem alarm as expected and in accordance with product specifications.Ge healthcare (gehc) attempted to contact the customer's biomedical engineer and risk manager on multiple occasions.The biomed eng responded once but could not provide any further details regarding the patient's status.The customer did not reply to gehc requests for access to test the telemetry system's alarm function or download log files for gehc engineering analysis.As part of a service request and prior to gehc receiving the medwatch report, gehc depot repair received the affected telemetry transmitter and noted that the bulkhead and battery contacts were corroded.The transmitter was also missing the battery door and serial port plug.The necessary service was performed on the device and it was returned to the customer.Due to the limited information available, gehc was unable to determine the root cause for the alleged missed no telem alarm, however, lack of clinical staff awareness of the no telem alarm at the central station may be a possible cause.Gehc did not identify any adverse trend related to no telem alarm.

• Brand Name: APEXPRO FH
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WIT
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• MDR Report Key: 10772086
• MDR Text Key: 214304503
• Report Number: 3008729547-2020-00007
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K033365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2025064-004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR