MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022)

Patient Problems Cardiac Arrest (1762); Death (1802); Ventricular Fibrillation (2130)

Event Date 11/17/2020

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The hospital's unit manager reported that a code blue event occurred the morning of (b)(6) 2020.The patient was in a paced rhythm then went into ventricular fibrillation, and with the change in rhythm, the red alarm for ventricular fibrillation did not sound.The patient was resuscitated then pronounced expired.The manager further stated that a hospital unit monitor technician reviewed the patient electrocardiograph strips (strips) and observed that a red alarm did not sound.

Manufacturer Narrative

A clinical specialist (cs) went to the hospital site and took pictures of the patient strips as well as a picture the cs titled ¿red alerts¿ that contained an excerpt from the audit log for the date and time frame of (b)(6), 2020 07:52:36 am to 08:21:55 am.Our philips product support engineer (pse) reviewed the pictures.The pse reviewed the pictures of the strip and confirmed that ***vent fib/tach alarms were being generated on the strips.***vent fib/tach is displayed on the strips for (b)(6), 2020 at 08:13 am and 08:14 am.Red alerts picture review: the pse reviewed the picture of the red alerts from the audit log and confirmed seeing ***vent fib/tach alarms on (b)(6), 2020 at 08:13 am, 08:14 am, 08:15 am, 08:16 am, 08:17 am, and 08:21 am.On (b)(6), 2020 at 08:20 am and 08:21 am ***asystole alarm was generated.It also shows that alarms were being acknowledged.Based on our investigation, philips determined the mx40 alarmed appropriately and operated as intended.The pse's evaluation was provided to the customer.The device remains at the hospital site.The investigation concluded the device did not caused or contribute to the adverse event.

Event Description

The hospital's unit manager reported that a code blue event occurred the morning of (b)(6) 2020.The patient was in a paced rhythm then went into ventricular fibrillation, and with the change in rhythm, the red alarm for ventricular fibrillation did not sound.The patient was resuscitated then pronounced expired.The manager further stated that a hospital unit monitor technician reviewed the patient electrocardiograph strips (strips) and observed that a red alarm did not sound.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10872118
• MDR Text Key: 217295858
• Report Number: 1218950-2020-07040
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 83