MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS M3155 INFO CNTR NETWORK DB REL N.01

Model Number 866094

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Asystole (4442)

Event Date 07/26/2023

Event Type  Death  

Event Description

The customer reported that there are clinical questions regarding alarm after a patient death.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Manufacturer Narrative

A complete investigation was performed by the philips team and the steward clinical engineering team.The findings indicates that all types of simulations were ran and it was determined that the pic classic system alarmed as programmed and designed.The length of the red alarm volume cannot be increased/decreased for red alarm notifications, except for the first initial alarm for brady or asystole.After the first alarm is silenced, the frequency to the next alarm occurring, and cannot be adjusted under unit program setting , accessed in service mode the default is set for the first timeout period alarm to 3 minutes, and the 2nd timeout to 10 minutes.Max volume sound can be set to 10, but is so blaring loud that it obliterates someone talking to someone else.Therefore, alarm volume setting is only set to a 4, which is audibly heard and adequately notifies nursing staff about all alarms, when they occur.The red alarm for brady and asystole are displayed with a flashing red banner , every 5 seconds, but there is no audible alarm that can be heard, as this is how pic classic is designed.Based on the information available and the testing conducted, the device was functioning as intended and there is no malfunction of the device.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: M3155 INFO CNTR NETWORK DB REL N.01
• Type of Device: M3155 INFO CNTR NETWORK DB REL N.01
• 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: 17597808
• MDR Text Key: 321677455
• Report Number: 1218950-2023-00591
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• 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: 866094
• Device Catalogue Number: 866094
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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