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 09/29/2017

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.Patient information has been requested but is not available at this time.

Event Description

The customer reported that a patient death occurred on (b)(6) at 2:44 am and the customer is questioning a possible safety issue involving an mx40.Details about the incident have not been provided.

Manufacturer Narrative

No malfunction of the device occurred.Evaluation of the device demonstrated wear and tear involving the battery adaptor tray and the use of unapproved cleaning agents.Log files demonstrate that a loss of communication between the device and the battery occurred at 02:45 which is at the time of the incident and logs from the central monitor support that a no signal inop was provided at that time which was silenced at the central by a user.The customer did not provide details regarding the actual incident therefore it could not be confirmed whether or not use of the device was an actual factor in the death of the patient.

• 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: wendy chadbourne ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6947739
• MDR Text Key: 89256081
• Report Number: 1218950-2017-07185
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 09/29/2017
• Supplement Dates FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• 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