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 Death (1802)

Event Date 11/20/2018

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.The leadset was off the patient and some hours later the patient had a cardiac event and expired.The customer alleged that the alarms may not have sounded and the mx40 device may have caused or contributed to the adverse event.

Event Description

The customer reported a patient death.The adverse event occurred between the hours of 2am and 8am for bed label (b)(6), and equipment label (b)(6).The device was in use monitoring the patient at the time of the event.

Manufacturer Narrative

The customer reported a patient death.The adverse event occurred (b)(6) 2018 between the hours of 2 am and 8 am for bed label 203, and equipment label imu04.Per the mx40 telemetry product support engineer, the mx40 review alarms log shows that a ecg leads off inop was provided at 04:03 on (b)(6) 2018, immediately followed by a leadset unplugged inop.This is consistent with disconnection of the lead set from the mx40 device.Note that upon disconnection of the lead set, the device will initially recognize loss of ecg data and provide an ecg leads off inop, which is then replaced by the leadset unplugged inop (for loss of communication with the lead set eeprom).The log also shows that the inop was silenced at 04:08 on (b)(6) 2018.The mx40 was sending data to the piic as specified.At 04:03 am on (b)(6) 2018, the lead set was disconnected from the mx40, and ecg leads off and leadset unplugged inops were generated as appropriate and as designed.The ecg leads off / leadset unplugged inop was silenced at the piic, indicating that the alarm was provided, and then recognized and responded to by staff.The device was returned to the factory where the product support engineer concluded that there was no data to support a malfunction; the device performed as specified.The mx40 device was updated to the latest hardware and software and returned to the customer.

• 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: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8137463
• MDR Text Key: 129465027
• Report Number: 1218950-2018-09447
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: (01)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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865350
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• 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: 86 YR
• Patient Weight: 121