MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC PAGEWRITER TC 20 CARDIOGRAPH

Model Number 860332

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the frame was damaged from a fall.No other information was provided.The device was not in use on a patient at the time of the event.The pagewriter tc10 cardiograph (model number 860392) is substantially similar to the pagewriter tc20 cardiograph (model number 860332) and will be reported in the united states under device model number 860332 (cfn/fei # (b)(4); 510k k113144).

Event Description

The customer reported that the frame was damaged from a fall.The device was not in clinical use at the time the reported issue was discovered.

Manufacturer Narrative

A repair technician was sent to assist the customer.A good faith effort was completed to determine how the unit fell, but no response was received.It is unknown how the customer's issue was resolved.

• Brand Name: PAGEWRITER TC 20 CARDIOGRAPH
• Type of Device: PAGEWRITER TC 20 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• MDR Report Key: 11832588
• MDR Text Key: 250905257
• Report Number: 1218950-2021-10547
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• PMA/PMN Number: K113144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,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: No Information
• Device Model Number: 860332
• Device Catalogue Number: 860332
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1