MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC70 CARDIOGRAPH

Model Number	860315
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the metal frame holding the wheel casters snapped off at one corner on their new (b)(4) cart.The device was not in use on a patient at the time of the event.
Additional Manufacturer Narrative
H3 other text : device problem known.Customer was sent a replacement.
Event or Problem Description
Customer reported that the metal frame holding the wheel casters snapped off at one corner on their new tc70 cart.There was no patient harm or injury reported.The device was not in use on a patient at the time of the event.
Additional Manufacturer Narrative
This supplemental report is created with reference to mfg report #1218950-2021-10813 with corrected information to update the manufacturing site.H3 other text : device problem known.Customer was sent a replacement.
Event or Problem Description
Customer reported that the metal frame holding the wheel casters snapped off at one corner on their new tc70 cart.There was no patient harm or injury reported.The device was not in use on a patient at the time of the event.

• Brand Name: PAGEWRITER TC70 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC70 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; building 5 suite 203; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; building 5 suite 203; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12317809
• Report Number: 1218950-2021-10813
• Device Sequence Number: 14588223
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: 00884838026582
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: 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
• Device Model Number: 860315
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/21/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 07/21/2021; 07/21/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 11/04/2021; 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown