MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 1.4 GHZ SMART HOPPING

Model Number 865350

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 02/10/2021

Event Type  Injury  

Event Description

The hospital biomed requested assistance in obtaining logs.It was reported a patient was harmed and the customer needs log information to see if it was a device error or not.Additional information about incident and patient was requested.The device was in use on a patient at the time of event and adverse event reported.

Manufacturer Narrative

The device was not expected to be returned for evaluation.Good faith efforts were made to discover the event details, however no additional information was provided.

Event Description

The hospital biomed requested assistance in obtaining logs.It was reported a patient was harmed and the customer needs log information to see if it was a device error or not.Additional information about incident and patient was requested.The device was in use on a patient at the time of event and adverse event reported.

• Brand Name: MX40 1.4 GHZ SMART HOPPING
• Type of Device: MX40 1.4 GHZ SMART HOPPING
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 11425105
• MDR Text Key: 238312188
• Report Number: 1218950-2021-10085
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838082236
• UDI-Public: 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2021
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2011
• 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): Hospitalization