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

Model Number 860310

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Phone provided: (b)(6).A follow-up report will be submitted upon completion of the investigation.

Event 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 Description

The customer reported the device suffered a fall.The device was not in clinical use at the time the reported issue was discovered.

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
• Type of Device: PAGEWRITER TC50 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11777347
• MDR Text Key: 249057516
• Report Number: 1218950-2021-10508
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00884838026568
• UDI-Public: 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: user facility
• 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: 860310
• Device Catalogue Number: 860310
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/13/2021
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1