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

Model Number 865350

Device Problems Device Alarm System (1012); Unexpected Shutdown (4019)

Patient Problem Injury (2348)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The customer alleged a serious injury had occurred when the bedside monitor (mx40) had been shut off.The customer stated that no alerts were programmed to sound when this happens (the device was shut off).The customer stated that the mx40 was being used on a patient for monitoring.The customer reported via medwatch that there was a serious injury of unknown extent or type.

Manufacturer Narrative

The device has not been received for evaluation.The root cause of the allegation of failure to alarm is unknown due to insufficient information.The event is considered reportable based on the customer allegation.In the event that the device is returned, the record shall be reopened for further 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
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8566698
• MDR Text Key: 143617923
• Report Number: 1218950-2019-03206
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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
• Date Manufacturer Received: 04/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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