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

Model Number 865351

Device Problems Device Alarm System (1012); Alarm Not Visible (1022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2022

Event Type  malfunction  

Event Description

The customer reported that the mx40 does not properly display the arrhythmia alarms anymore.It is unknown if the device was in clinical use at the time of the event, no adverse event or patient harm was reported.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported that the mx40 does not properly display the arrhythmia alarms anymore.The fse confirmed that the device was not in clinical use and there was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.The fse was unable to determine the cause of the alarm failure.The customer was provided a replacement device to resolve the issue.

Manufacturer Narrative

The device was sent to philips bench repair for evaluation.The bench repair technician states that the device was speaker was properly working and that the device did link and function correctly on the piic.The bench repair technician did note that the device had multiple failures of the display; scratches and delamination on bezel, lcd dimming to age, and a foggy film bezel display.The customer previously received a replacement device.

• 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 rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15757198
• MDR Text Key: 305242194
• Report Number: 1218950-2022-00986
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 01/23/2023; 08/02/2023
• Supplement Dates FDA Received: 01/25/2023; 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2012
• 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