MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2023

Event Type  Death  

Event Description

It was reported that the customer would like to have the tele mx40 checked, as the device was involved in a patient death.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Manufacturer Narrative

The clinical specialist reviewed the available audit logs provided which showed alarms for both physiological limit violations which were acknowledged and ecg leads off technical inops.While the device was connected to the network/pic ix, alarms were being provided for physiological and technical alarm conditions.Lost connectivity with the network/pic ix could not be determined with the available data.Additional information was later supplied by the field service engineer.A philips product support engineer reviewed the available log information.The audit log shows that the device was going online and offline continuously during the incident timeframe.While the device was connected to the network/pic ix, alarms were being provided at the pic ix, and users were acknowledging the alarms.When the mx40 was disconnected from the pic ix, a ¿no data tele¿ technical inop (visual/audible alarms) at the sector of the pic ix and the mx40 would have been in monitor mode (providing alarms at the device as appropriate).The mx40 pwm logs were not captured for review prior to the device being returned to bench repair and the rfda log data captured started on 03-jul-2023 (well beyond the incident date).The devicedebug log data captured indicates there was a battery change at 23:31 on 01-jun-2023.Based on battery voltage at boot-up, aa batteries and the battery adapter tray were being used.The devicedebug log also shows ongoing disconnects/failures to connect with an access point from 15:54 on 02-jun-2023 through 17:58 on 02-jun-2023.The disconnects appear to be related to marginal to poor signal strength (with some exceptions).Mx40 unsuccessfully attempting to connect to network.Recommend performing a coverage area verification to determine if there is an issue with the access point or coverage (proper overlap of ap zones or if there is some other interference/obstruction on the area of use.The engineer provided their analysis findings.It was recommended performing a coverage area verification to determine if there is an issue with the access point or coverage (proper overlap of ap zones or if there is some other interference/obstruction on the area of use.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17248667
• MDR Text Key: 318299586
• Report Number: 1218950-2023-00455
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Date Device Manufactured: 09/17/2015
• 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
• Patient Outcome(s): Death
• Patient Sex: Female