MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problem Alarm Not Visible (1022)

Patient Problems Arrhythmia (1721); Loss of consciousness (2418)

Event Date 12/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported that a patient with suspected arrhythmia lost consciousness.It was alleged that no asystole alarms came from the monitor.

Manufacturer Narrative

An analysis of the reported incident was unable to be conducted thoroughly by a philips product support engineer (pse) as the piic and mx40 device logs (¿logs¿) requested did not contain relevant data for the timeframe of the event on (b)(6) 2019, along with one patient strip obtained from the mx40.The mx40 was trying to analyze data, as evidenced by the beat annotations in the patient strip.The mx40 labeled 6 questionable beats as ¿?¿.This would prevent the asystole alarm from occurring.The patient strip provided did not meet the criteria for an asystole alarm.Based on our investigation, there is insufficient information to make a determination on how the mx40 was functioning during the time of the incident described above.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

The customer reported that a patient with suspected arrhythmia lost consciousness.It was alleged that no asystole alarms came from the monitor.Patient with suspect arrhythmia loses consciousness combined with no qrs complexes.Patient received a pacemaker and recovered well.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9508458
• MDR Text Key: 172414050
• Report Number: 1218950-2019-09660
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 38