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

Model Number 865350

Device Problem Defective Alarm (1014)

Patient Problem Insufficient Information (4580)

Event Date 04/17/2023

Event Type  Death  

Event Description

It was reported that alarms were not working.A patient death was reported.

Manufacturer Narrative

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

Manufacturer Narrative

It was confirmed that the mx40 did not contribute to the adverse event.Based on review of the available data, the monitoring equipment was functioning as specified.The philips product support engineer (pse) reviewed the available data/logs for bed 352-2 on (b)(6)2023 from 10:12 to 11:01.The device was confirmed to be operating per specifications and no failure was identified.It was recommended to the customer that the alarm volume at the central station be louder as it was difficult to hear in the open area of the unit.The device remains at customer site.

• 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 rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16915586
• MDR Text Key: 315062516
• Report Number: 1218950-2023-00320
• 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: Foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Device Catalogue Number: 865350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2022
• 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