MAUDE Adverse Event Report: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS CATALOG ITEM NAME

Model Number	453564483321
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	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
Onsite philips field service engineer (fse) reported that after reloading the software for an unrelated issue, the ecg traces would then sometimes go fast or abnormally slow (sweep speed).There was no reported patient impact / injury.
Event or Problem Description
Onsite philips field service engineer (fse) reported that after reloading the software for an unrelated issue, the ecg traces would then sometimes go fast or abnormally slow (sweep speed).The device was not in use on a patient at the time of event, there was no patient involvement.
Additional Manufacturer Narrative
H10: corrections made to section d where product name, model number, serial number is updated.Section h: manufacture date corrected.
Event or Problem Description
Onsite philips field service engineer (fse) reported that after reloading the software for an unrelated issue, the ecg traces would then sometimes go fast or abnormally slow (sweep speed).The device was not in use on a patient at the time of event, there was no patient involvement.

• Brand Name: CATALOG ITEM NAME
• Common Device Name: CATALOG ITEM NAME
• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12477427
• Report Number: 1051786-2021-10050
• Device Sequence Number: 3939470
• Product Code: MWI
• UDI-Device Identifier: 00884838082113
• UDI-Public: 00884838082113
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K101571
• 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,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: 453564483321
• Device Catalogue Number: 453564483321
• 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: 08/31/2021
• Supplement Date Received by Manufacturer: 08/31/2021; 08/31/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 12/13/2021; 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2015
• 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