MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC70 CARDIOGRAPH

Model Number 860315

Device Problem Defective Component (2292)

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

Event Date 07/21/2021

Event Type  malfunction  

Event Description

Customer reported that the metal frame holding the wheel casters snapped off at one corner on their new (b)(4) cart.The device was not in use on a patient at the time of the event.

Manufacturer Narrative

H3 other text : device problem known.Customer was sent a replacement.

Event Description

Customer reported that the metal frame holding the wheel casters snapped off at one corner on their new tc70 cart.There was no patient harm or injury reported.The device was not in use on a patient at the time of the event.

Manufacturer Narrative

This supplemental report is created with reference to mfg report #1218950-2021-10813 with corrected information to update the manufacturing site.H3 other text : device problem known.Customer was sent a replacement.

Event Description

Customer reported that the metal frame holding the wheel casters snapped off at one corner on their new tc70 cart.There was no patient harm or injury reported.The device was not in use on a patient at the time of the event.

• Brand Name: PAGEWRITER TC70 CARDIOGRAPH
• Type of Device: PAGEWRITER TC70 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; building 5 suite 203; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; building 5 suite 203; andover MA 01810
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12317809
• MDR Text Key: 266370000
• Report Number: 1218950-2021-10813
• 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: K080999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Model Number: 860315
• Device Catalogue Number: 860315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/21/2021
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 07/21/2021; 07/21/2021
• Supplement Dates FDA Received: 11/04/2021; 12/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1