MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLIBRIDGE EC40/80

Model Number	865056
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported: : the auto-charting made that strictly the same data were transferred to the intellispace critical care and anesthesia (icca), while this varies on the respirator (in particular for the measured data).So incorrect data in icca, and the data has to be corrected manually, despite the burdensome covid situation.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.
Event or Problem Description
The auto-charting made that strictly the same data were transferred to the intellispace critical care and anesthesia (icca), while this varies on the respirator (in particular for the measured data).So incorrect data in icca, and the data has to be corrected manually, despite the burdensome covid situation.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• Brand Name: INTELLIBRIDGE EC40/80
• Common Device Name: INTELLIBRIDGE EC40/80
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13258280
• Report Number: 1218950-2022-00045
• Device Sequence Number: 1546556
• Product Code: MHX
• UDI-Device Identifier: 00884838090811
• UDI-Public: 00884838090811
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 865056
• Device Catalogue Number: 865056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2021
• 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