MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC TELE PWM,802.11A/B/G,ECG ONLY,EX,NON US

Model Number 865352

Device Problems Loss of Data (2903); Wireless Communication Problem (3283)

Patient Problem Insufficient Information (4580)

Event Date 09/26/2022

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information regarding the reported event and the investigation is ongoing.A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer stated that around 12 midnight the device started saying no data on the central station.So they changed battery and they could see it was taking trace but then again the telemetry seemed to connect to central for a bit (20 mins) then on the central it was saying no data.Customer wanted to check if there was a way to retrieve the data from the telemetry as the doctors want the information from around midnight up to 6 am, as they say the patient was still connected to the same telemetry.(i explained that patient data/ecg can not be retried from the tele unit since it was not connected to the central station).A patient died.

Event Description

After further investigation, it was determined that the cause was on the customer's network and not philips product.The customer reported that the mx40 device failed to transmit alarms to the central station.The audit logs show the physiological alarms that were provided while the mx40 was connected to the network/pic ix (from 00:08 until 00:25 on (b)(6) 2022).The mx40 was offline (not communicating with the pic ix from 00:25:16 until 06:19:34 on (b)(6) 2022).The users should have been aware of the loss of communication between the mx40 and the pic ix from 00:25:16 through 06:19:34 on (b)(6) 2022.There was no malfunction of the philips device.Testing of the mx40 and review of log data indicates that the mx40 was operating to specifications.The customer has also confirmed that the dropouts are caused due to hospital infrastructure/network changes.

• Brand Name: TELE PWM,802.11A/B/G,ECG ONLY,EX,NON US
• Type of Device: TELE PWM,802.11A/B/G,ECG ONLY,EX,NON US
• 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: 15547419
• MDR Text Key: 301232599
• Report Number: 1218950-2022-00910
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838030350
• UDI-Public: 00884838030350
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• 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: 10/05/2022
• 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: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2018
• 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