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

Model Number 865350

Device Problem Alarm Not Visible (1022)

Patient Problem Bradycardia (1751)

Event Date 05/31/2022

Event Type  Death  

Manufacturer Narrative

The clinical audit logs were provided and were reviewed by the philips clinical product specialist.The clinical product specialist (cps) analyzed the clinical audit logs and noted that there many yellow and red alarms leading to the time of treatment 13:00.The cps indicated that the alarms were generated appropriately and were acknowledged by the tele technician.The clinical product specialist determined that there was no malfunction of the philips device as the device was functioning as designed.Based on the log information, the device did alarm when it was supposed to.Based on the performed investigation, philips has determined that he mx40 device working as intended.

Event Description

The customer reported that the device failed to alarm when there was a change of rhythm and rate, which led to a bradycardic event.The device was in use and a patient death was 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14829583
• MDR Text Key: 294774028
• Report Number: 1218950-2022-00518
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 00884838082236
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 76 KG