MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PAGEWRITER TC30 CARDIOGRAPH

Model Number	860306
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
The customer reported that following a fall, the device had several broken parts.Good faith efforts (gfe) have been made by the investigator to obtain additional information regarding how the device fell without a response.No additional information has been provided.There was no reported patient impact/injury.

• Brand Name: PAGEWRITER TC30 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC30 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11376362
• Report Number: 1218950-2021-10024
• Device Sequence Number: 19842946
• Product Code: DPS
• UDI-Device Identifier: 00884838081123
• UDI-Public: 00884838081123
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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

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: 860306
• Device Catalogue Number: 860306
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1