MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC70 CARDIOGRAPH

Model Number	860315
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection found the bottom frame of the cart is broken.A cart was provided from biomed to hold the ekg unit until a new cart could be obtained.The customer was provided part ids to order a new cart.Based on the information available and the testing conducted, the cause of the reported problem was physical damage to the fame of the cart.The reported problem was confirmed.The customer was provided a part id for a replacement cart to resolve the issue.
Event or Problem Description
Philips received a complaint on the pagewriter tc70 cardiograph indicating that the wheel broke off the ekg cart while moving it.The device was in use on patient at time of event, there was no adverse event reported.

• Brand Name: PAGEWRITER TC70 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC70 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: 21080459
• Report Number: 1218950-2025-000009
• Device Sequence Number: 6832273
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: (01)00884838026582
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113144
• 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
• Report Date (Section B): 01/06/2025

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: 860315
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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