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

Model Number 865350

Device Problem Battery Problem (2885)

Patient Problem Death (1802)

Event Date 01/15/2020

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.Serial number not provided.

Event Description

The customer reported the device's battery died during the night without anyone's knowledge.The customer states the patient was found six (6) hours later with no pulse.

Manufacturer Narrative

H10: good faith effort was made to determine if the device will be returned for evaluation.The device will not be returned for evaluation.The hospital's biomed concluded the device functioned as intended."the event was not related to any unexpected failure of philips equipment.Philips equipment did what it was supposed to do, no issues with the operation of the equipment." pg 135-136 of the instructions for use (ifu) contains information on battery power including lifetime management.The hospital's biomed stated, "we have it worked out.From the equipment side all is working.It¿s up to nursing next steps for monitoring." the device remains at the customer site.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.H3 other text : the device will not be returned for evaluation.

• 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: 9612635
• MDR Text Key: 175737159
• Report Number: 1218950-2020-00438
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death