MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem False Alarm (1013)

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

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete. fda procode updated based on information known at this time.Catalog item id is unknown and unable to acquire through initial reporting activities.

Event Description

The customer reported that the mx40 monitor failed to generate an alarm for the lower alarm limit for the heart rate (hr) parameter.The device was in use at time of event, there was no adverse event reported.

Event Description

Complaint evaluation: based on the evaluation performed by the service engineer, the reported issue was not replicated during evaluation.The service engineer indicated that the device generated the alarm as intended.Customer resolution and conclusion: the service engineer confirmed that the device was operating normally and the device was returned to service.Problem statement: the customer reported that the mx40 monitor failed to generate an alarm for the lower alarm limit for the heart rate (hr) parameter.While there has been no report of patient/user death or serious injury in this case, this event is considered reportable due to the potential that the device may fail to alert users to deterioration of a patient¿s condition.The issue is not associated with a death, serious injury, product design, or labeling deficiency.Was the device being used on a patient at the time of the event, including for the purposes of diagnosis? yes, the device was in use on a patient at the time of event.Was there any adverse event to the patient or user? if yes, describe? no, there was no adverse event reported.If there was an adverse event, did the device cause or contribute to the adverse event, and how? no, there was no adverse event reported.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15391442
• MDR Text Key: 302418784
• Report Number: 1218950-2022-00869
• Device Sequence Number: 1
• Product Code: DXH
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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