MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH

Model Number	860310
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.Reporting address state: (b)(6).
Event or Problem Description
The customer reported that the device had fallen and was very damaged; the rear cover is damaged, some screws have been lost, and the power supply connecting has been damaged as well.It is unknown if the device was in clinical use at the time the device fell.There was no adverse event or patient harm reported.It was unknown if the fall was an accidently drop, or if the device fell due to a mounting issue.
Additional Manufacturer Narrative
A request was made to determine the cause of the fall.But no information was provided.The device was operational after repairs were completed.All tests passed as designed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
Additional Manufacturer Narrative
Data correction to device identifier.
Additional Manufacturer Narrative
D4 updated and corrected the unique identifier.
Additional Manufacturer Narrative
Data correction to device identifier.The manufacturing date for the reported device is prior to (b)(6)2016 so no udi required.
Additional Manufacturer Narrative
D4 updated unique identifier.

• Brand Name: PAGEWRITER TC50 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC50 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18041500
• Report Number: 1218950-2023-00829
• Device Sequence Number: 18009687
• Product Code: DPS
• UDI-Device Identifier: 00884838026568
• UDI-Public: (01)00884838026568
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080999
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/16/2024

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: 860310
• Device Catalogue Number: 860310
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 10/19/2023; 06/11/2024; 06/11/2024; 07/08/2024; 07/08/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/15/2023; 06/12/2024; 06/13/2024; 07/10/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2011
• 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