MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS EXPRESSION INFORMATION PORTAL (IP5)

Model Number	865471
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No functional analysis or testing was performed.Philips was unable to confirm the final disposition of the device, because the customer refused support and was taking responsibility for servicing the device.The cause of the reported problem was not confirmed.A philips remote service engineer (rse) recommend to the customer an exchange, and the customer indicated they would like the item shipped to them.The investigation concludes that no further action is required at this time.H3 other text : customer resolving on their own.
Event or Problem Description
The customer reported that there was no sound in the qrs tone on the ip5.They advised the touchscreen does not beep when touching as well, and advised that qrs was set to off, but when turned back on they still had no sound.Per the caller, all the alarms are set to volume 10.The device was in clinical use at the time 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)
• Manufacturer (Section D): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer (Section G): INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS; 12151 research parkway; orlando FL 32826
• Manufacturer Contact: hisham alzayat ; 12151 research parkway; orlando, FL 32826 ; 4072753220
• MDR Report Key: 19078448
• Report Number: 1051786-2024-00001
• Device Sequence Number: 20502428
• Product Code: MWI
• UDI-Device Identifier: 00884838031890
• UDI-Public: 00884838031890
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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 Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2016
• 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
• Patient Sex: Unknown