MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIBRIDGE EC10

Model Number	865115
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an alarm generated in yellow on a prismax equipment is transcribed in blue on an mx750 monitor.The customer expects the "dyls empty bag" alarm to be considered as a critical alarm and not a technical alarm.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.
Additional Manufacturer Narrative
Reporter's phone# (b)(6).A follow up report will be submitted once the investigation is complete.The mx750, is reported in under (b)(4).
Additional Manufacturer Narrative
Based on a review of the issue by product support engineering, this event appears to be an enhancement request.The 'bag empty' alarm on the non-philips prismax displays as a yellow technical alarm, which was defined as a low-priority alarm.This alarm is then transferred to the intellivue monitor, which displays "dialysate empty" as a cyan technical inop alarm, which is correct.Based on this information, there was no device malfunction and no harm occurred.This is no longer considered a reportable event.

• Brand Name: INTELLIBRIDGE EC10
• Common Device Name: INTELLIBRIDGE EC10
• 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, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 16270575
• Report Number: 9610816-2023-00052
• Device Sequence Number: 15326565
• Product Code: MHX
• UDI-Device Identifier: 00884838015951
• UDI-Public: 00884838015951
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082583
• 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 Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 865115
• Device Catalogue Number: 865115
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown