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

Model Number 865350

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 05/24/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The customer reported that an mx40 device was in use on thursday (b)(6) between (8 pm and 12 midnight )and while ecg waveforms could be viewed on the local mx40, the data was not communicated to the information center ix.During this time a leads off inop occurred and the patient expired.

Manufacturer Narrative

The customer called the customer care solutions center for troubleshooting support and the call was dispatched for onsite evaluation by a philips field service engineer (fse).The fse stated he followed the testing process per the mx40 service and installation manual and confirmed the device passed performance testing.The fse did indicate that the leadset connector had corrosion noted on pin 4 and the leadset that was in use at the time of the event was not provided for evaluation.The customer was requested to release the device for return via return materials authorization (rma) to philips (b)(4).For full performance testing but the customer declined to release the device.Audit log data from the information center ix supports that the central received a leadset unplugged indication from the device at 9:26:32 which was silenced at 9:27.The condition did not end until 10:31 when the device entered standby.Testing by a philips fse found the product performing as expected and no data transmission issues between the mx40 device in use and the information center ix.No malfunction occurred.As the customer did not agree to any further formal testing of the mx40 device itself other than onsite performance testing, no further action or investigation is warranted.The results of the investigation have been provided to the customer via a formal letter which was then followed by a teleconference to answer remaining questions.

• 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 road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7611051
• MDR Text Key: 111384632
• Report Number: 1218950-2018-05041
• Device Sequence Number: 1
• Product Code: DSI
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• 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