MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX

Model Number	866389
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi is not available at this time due to unknown software revision.Software revision has been requested.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the pic overview 3 station was missing red extreme brady alarms audible and visual for bed 8 ne in room 19.The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
The following functional tests were performed: the customer received remote application assistance from a remote clinical support (rcs), who gathered the logs and screenshots.For further evaluation, the data was forwarded to product support engineering (pse).It appeared that alarm latching was set for split latching, visually latched for red only and audible latching was off.This means, that the asystole banner would stay on the screen until acknowledged, but the sound would stop when the condition ended.According to the screenshot available, that alarm lasted 10 min 17 sec ¿ none of the logs provided indicate alarm sound played.Therefore philips cannot determine, when the asystole condition actually ended.The provided data revealed, that a xbrady alarm was generated on the central station (ov3), which was immediately followed by an asystole alarm that persisted until the alarm was acknowledged at the monitor approximately 10 minutes later.Based on the information available and the testing conducted, the device was working as intended and there was no malfunction.The cause of the reported problem was due to user knowledge.The engineer provided their analysis findings and confirmed that device to be operating per specifications and no failure was identified.If additional information is received the complaint file will be reopened.
Event or Problem Description
It was reported that the pic overview 3 station was missing red extreme brady alarms audible and visual for bed 8 ne in room 19.The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: PATIENT INFORMATION CENTER IX
• Common Device Name: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 70314632031
• MDR Report Key: 21581703
• Report Number: 9610816-2025-000190
• Device Sequence Number: 21056854
• Product Code: MHX
• UDI-Device Identifier: 00884838112070
• UDI-Public: (01)00884838112070(10)4.1.0.0
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• 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
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG