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

Model Number 865352

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2022

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that a patient died between 11pm and 4am on the night of (b)(6).Remedial measures were carried out.Gaps in patient monitoring was noticed by the nursing staff.

Event Description

The customer reported that a patient died between 11pm and 4am on the night of may 25th to 26th.Remedial measures were carried out.Gaps in patient monitoring was noticed by the nursing staff.

Manufacturer Narrative

A philips product support engineer (pse) reviewed the logs.According to the pse, the device.Debug and rfda logs showed that there were 27 mx40 device reboot events during the time of the event.While the device was connected to the pic ix, alarms were provided for limit violation events (including ***xbrady, ***vtach, and *** asystole).The device reboot events were not associated with battery replacement (based on voltages captured at the times of the reboots) which is consistent with momentary power interruptions.The reported failure could be related to damage to one or both battery retention tabs of the mx40.A request for photos of the mx40 including battery contacts was made.However, the photos were not provided.Based on the foregoing investigation, philips healthcare has determined that the allegation against the telemetry device cannot be confirmed due to insufficient information.

• 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: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14605398
• MDR Text Key: 293428155
• Report Number: 1218950-2022-00455
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865352
• Device Catalogue Number: 865352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 151 KG