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

Model Number 860315

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

Customer reported the trolley has a broken caster mount for the wheel.There was no patient harm or injury reported.

Manufacturer Narrative

Customer reported the issue via the customer care solutions center(ccsc) who suggested creating a defoa so the sales rep could send a replacement cart to the customer.The sales rep logged a defoa and it was approved and the replacement cart sent to the customer.Per good faith effort attempts, it was determined the cart had been in clinical use for 4 weeks already when the damage occurred.It is unknown if it was in clinical use at the time the damage occurred.An attempt was made to send the customer a new box as they had lost the original box to return the damaged cart, however, the cart has not yet been received.There was no shipping damage noted to the original box.The cart was used successfully for 4 weeks.It is unknown exactly how the damage occurred, however, based on photographs, it appears to be a hardware defect.

Event Description

Customer reported the trolley has a broken caster mount for the wheel.Patient involvement is unknown.There was no report of patient or user harm.

• 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: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12660132
• MDR Text Key: 277261960
• Report Number: 1218950-2021-11036
• Device Sequence Number: 1
• Product Code: DPS
• 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
• Remedial Action: Replace
• 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?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 12/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2021
• 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