MAUDE Adverse Event Report: EXPRESSION INFORMATION PORTAL (IP5)

Model Number	865471
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the dr.Claimed that the nbp readings are not updating on the ip5 display (in the nbp section) but they can see the nbp readings within the trend menu.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 customer reported that the doctor claimed that the nibp (non-invasive blood pressure) readings were not updating on the ip5 display (in the nbp section) but they could see the nbp readings within the trend menu on the complaint device.The complaint device was in clinical use at the time that the issue was discovered.There was no adverse event, or patient harm reported.

• Brand Name: EXPRESSION INFORMATION PORTAL (IP5)
• Common Device Name: EXPRESSION INFORMATION PORTAL (IP5)
• MDR Report Key: 12246608
• Report Number: 1051786-2021-10040
• Device Sequence Number: 14152122
• Product Code: MWI
• UDI-Device Identifier: 00884838031890
• UDI-Public: 00884838031890
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131382
• 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 faci
• 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: 865471
• Device Catalogue Number: 865471
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/22/2021
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 10/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2016
• 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