MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PAGEWRITER TC50 CARDIOGRAPH

Model Number	860310
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	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone provided: (b)(6).A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported the device suffered a fall.The customer refused to provide any further information on how the device fell.The device was not in use on a patient at the time of the event.
Event or Problem Description
The customer reported the device suffered a fall.The device was not in clinical use at the time the reported issue was discovered.
Additional Manufacturer Narrative
A third-party repair group (promovendo brasil) was contacted to evaluate the device.The third party provided the customer with a quote to have the device evaluated.However, the customer has declined the quote for further evaluation and corrective action of the device.

• Brand Name: PAGEWRITER TC50 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC50 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11777347
• Report Number: 1218950-2021-10508
• Device Sequence Number: 17143388
• Product Code: DPS
• UDI-Device Identifier: 00884838026568
• UDI-Public: 00884838026568
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K080999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• 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: Health Professional
• Device Model Number: 860310
• Device Catalogue Number: 860310
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/13/2021
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1