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

Model Number 865351

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Tachycardia (2095); Dizziness (2194)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer reported the device was connected to the patient with the heart rate alarms set between 50-120 beats per minute (bpm).When the patient walked to the bathroom, their heart rate increased to 190 bpm and the patient became dizzy and fell.The customer indicated the device failed to alarm.The patient walked to the bathroom, their heart rate increased to 190 bpm and the patient became dizzy and fell.

Manufacturer Narrative

A philips product support engineer reviewed the device logs and found that they show ongoing alarms for hr > 120, and some xtachy alarms > 140.There was an xtachy alarm in effect starting at 09:18, which would have been the active alarm at the time of the reported hr of 190 bpm at 10:47 but there was already an active alarm for xtachy.It appears that this alarm was not responded to (silenced) until 11:03.There was no product malfunction as the device did alarm and is considered to be a user related issue as the alarm was not responded to (silenced) until a certain time.

• 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
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8934430
• MDR Text Key: 155630153
• Report Number: 1218950-2019-06445
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: (01)00884838082243
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

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: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 08/27/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2018
• 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