MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TOUCH CARDIOGRAPH; PAGEWRITER TC70 CARDIOGRAPH

Model Number	860315
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone not provided.Customer did not provide serial number.Philips approved the defoa and sent a replacement trolley to the customer.Replacing the trolley resolved the issue.Investigation cannot be concluded as the trolley could not be investigated due to covid-19.
Event or Problem Description
The customer reported the caster snapped off the cart upon arrival.There was no patient involvement.

• Brand Name: PAGEWRITER TOUCH CARDIOGRAPH
• Common Device Name: PAGEWRITER TC70 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10174179
• Report Number: 1218950-2020-03568
• Device Sequence Number: 13661766
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: (01)00884838026582
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K020708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1