MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number	866389
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2023, there was a failure to alarm for bradycardia at the central station and the bedside monitor.The device was in use and the monitor displayed a heart rate of 54 bpm, which was outside the set parameters (high limit-200 bpm and low limit-100 bpm).It was indicated the bradycardia was not managed in time.
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This record was confirmed to be a duplicate of the event reported in mfr report number 1218950-2023-00820.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• 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: 18256471
• Report Number: 1218950-2023-00908
• Device Sequence Number: 6600510
• Product Code: MHX
• UDI-Device Identifier: 00884838104594
• UDI-Public: 00884838104594
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• 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
• Operator of Device: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Sex: Unknown