MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 2.4 GHZ SMART HOPPING

Model Number 865351

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2021

Event Type  malfunction  

Event Description

The hospital's biomed reports the mx40 telemetry device had no sound even on the max volume setting.Biomed confirms that there was no sound from the speaker, volume was set to max.No patient involvement.

Event Description

The hospital's biomed reports the mx40 telemetry device had no sound even on the max volume setting.Biomed confirms that there was no sound from the speaker, volume was set to max.No patient involvement.

• Brand Name: MX40 2.4 GHZ SMART HOPPING
• Type of Device: MX40 2.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11415165
• MDR Text Key: 238646110
• Report Number: 1218950-2021-10075
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082243
• UDI-Public: 00884838082243
• 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,health professional,u
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 865351
• Device Catalogue Number: 865351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Distributor Facility Aware Date: 02/25/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1