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

Model Number	865115
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the value for the inspired time displayed on the intellivue mp70 patient monitor was much higher than the actual reading on the maquet servo-i ventilator when using the intellibridge ec10 module.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
A philips clinical application specialist (cas) spoke to the customer.The customer stated that the inspiration time set on the servo-i ventilator was.63, but they were seeing a value of 32.3 on the monitor.The customer had previously reloaded the driver on the intellibridge ec10 module, but the reported issue recurred.During the investigation, the cas researched data on the servo-i ventilator and provided the customer with the following information from the instructions for use (ifu) for the ventilator: "differences in displayed values.Differences in displayed values between intellibridge and the maquet servo-i ventilator: the values sent to the intellibridge device from the maquet servo-i ventilator may not be identical to the values sent to its own display due to, for example, rounding up/down or differences in resolution." this information was emailed to the customer for further reference.Additionally, the customer was advised to replace the ec10 module as a preventive measure and the part number for a replacement intellibridge ec10 module was provided.The part number for a replacement module was provided.Based on the available details, the exact cause for the reported issue could not be established.

• Brand Name: INTELLIBRIDGE EC10 MODULE
• Common Device Name: INTELLIBRIDGE EC10 MODULE
• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12960015
• Report Number: 9610816-2021-10532
• Device Sequence Number: 1792334
• Product Code: MHX
• UDI-Device Identifier: 00884838015951
• UDI-Public: 00884838015951
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 865115
• Device Catalogue Number: 865115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2015
• 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