MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC INTELLIVUE INFO CENTER IX

Model Number	866023
Medical Device Problem Code	Alarm Not Visible (1022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that an alarm did not occur when it should have at their philips information center ix (pic ix).The device was in use on a patient.There was no report of patient or user harm.
Additional Manufacturer Narrative
A philips response center engineer (rce) reached out to the customer for further information.The customer was not able to provide further information.The rce followed-up with the customer, and was advised to check with clinical staffs if they have encountered any issues with alarms.The customer informed the rce that no other issues have been reported.H3 other text : insufficient information was provided by the customer on the reported issue.The customer stated that no other issues have been reported.No further investigation or action is warranted at this time.
Event or Problem Description
The customer reported that an alarm did not occur when it should have at their philips information center ix (pic ix).The device was in use on a patient.There was no report of patient or user harm.

• Brand Name: INTELLIVUE INFO CENTER IX
• Common Device Name: INTELLIVUE INFO CENTER IX
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11879192
• Report Number: 1218950-2021-10595
• Device Sequence Number: 1099985
• Product Code: MHX
• UDI-Device Identifier: 00884838029620
• UDI-Public: 00884838029620
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102495
• Number of Events Summarized: 1
• Summary Report (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: 866023
• Device Catalogue Number: 866023
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/09/2021
• Initial Date Received by Manufacturer: 05/09/2021
• Supplement Date Received by Manufacturer: 05/09/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1