MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLIVUE MX40 802.11A/B/G

Model Number 865352

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2021

Event Type  malfunction  

Event Description

During product evaluation, the bench repair technician found no audio/no sound on the mx40 telemetry device.No patient involvement.

• Brand Name: INTELLIVUE MX40 802.11A/B/G
• Type of Device: INTELLIVUE MX40 802.11A/B/G
• 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: derek sammarco ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11382424
• MDR Text Key: 233748325
• Report Number: 1218950-2021-10032
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 865352
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Distributor Facility Aware Date: 02/04/2021
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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