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

Model Number 860315

Device Problem Mechanical Problem (1384)

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

Event Date 03/21/2022

Event Type  malfunction  

Event Description

The customer reported that the device's cart has a broken caster.It is unknown if the device was in use at time of event, no adverse event was reported.

Manufacturer Narrative

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

Event Description

The customer reported that the device's cart has a broken caster.The device was not in use at time of event, no adverse event was reported.

• Brand Name: PAGEWRITER TC70 CARDIOGRAPH
• Type of Device: PAGEWRITER TC70 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14135799
• MDR Text Key: 289442714
• Report Number: 1218950-2022-00345
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00884838026582
• UDI-Public: 00884838026582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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
• Device Operator: Health Professional
• Device Model Number: 860315
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1