MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH

Model Number 860310

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that the unit fell and broke.The device was in use on a patient.There was no patient or user harm reported.

Manufacturer Narrative

D10: the device was returned for repair.Date of product return was not provided.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: PAGEWRITER TC50 CARDIOGRAPH
• Type of Device: PAGEWRITER TC50 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10507034
• MDR Text Key: 207166858
• Report Number: 1218950-2020-05237
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00884838026568
• UDI-Public: (01)00884838026568
• Combination Product (y/n): N
• PMA/PMN Number: K080999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 860310
• Device Catalogue Number: 860310
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1