MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PHILIPS HOLTER SOFTWARE

Model Number	860292
Medical Device Problem Code	Date/Time-Related Software Problem (2582)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported some of their studies are not being correctly flagged as read even though the doctor is reading them.For one study, when searching for a patient study taken on one date, a study for a different date (same patient) appears and vice versa.A second study had only the last name of the patient and the first name was added later.No patient harm or injury was reported.It is unknown if the device was in use at time of event.

• Brand Name: PHILIPS HOLTER SOFTWARE
• Common Device Name: PHILIPS HOLTER SOFTWARE
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14759288
• Report Number: 1218950-2022-00504
• Device Sequence Number: 1350154
• Product Code: MLO
• UDI-Device Identifier: 00884838000469
• UDI-Public: 00884838000469
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010949
• 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: Other
• 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: 860292
• Device Catalogue Number: 860292
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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