MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PAGEWRITER TC70 CARDIOGRAPH

Model Number	860315
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported upon arrival, when they lifted the cart the wheels fell off.There was physical damage noted upon further inspection.No patient involvement.

• Brand Name: PAGEWRITER TC70 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC70 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11373155
• Report Number: 1218950-2021-10012
• Device Sequence Number: 17153249
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: 00884838026582
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K080999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,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: Other
• Device Model Number: 860315
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/08/2021
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1