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

Model Number 865350

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 05/31/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

The hospital's biomed reported that on (b)(6) 2020 the patient was found on the floor unresponsive and pulseless.Cpr was applied, however, resuscitation of the patient was unsuccessful.The date and time of the patient's death was (b)(6) 2020 at 03:42 am.The nurse's advised that leads were showing as disconnected, but there wasn't any indication of it being disconnected in the room.

Manufacturer Narrative

Based on our investigation, the device had physical damage caused by use of unsupported cleaners.And/or cleaning methodologies, that impacted the device¿s ability to monitor the patient and generate physiological alarms reliably.The device generated inop alarms, for patient-cable connectivity issues appropriately.At the repair bench, the case, including the pins, were replaced.And the device was updated to the latest manufacturing process, with all tests passing per specifications.The device was returned to the hospital site to resume use.(b)(4), addresses pin corrosion and was issued to provide education on the proper cleaning techniques for mx40 telemetry devices.(b)(4), addresses mx40 and accessories.And was issued to provide education on the proper cleaning techniques for mx40 telemetry devices and their accessories.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• 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
• MDR Report Key: 10132499
• MDR Text Key: 194458722
• Report Number: 1218950-2020-03331
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K113125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 62 YR
• Patient Weight: 56