MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC PAGEWRITER TC50 CARDIOGRAPH

Model Number	860310
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that an "external fuse blows up".Patient involvement is currently unknown.There was no report of patient or user harm.
Event or Problem Description
The customer reported that an "external fuse blows up".The device was not in clinical use at the time the reported issue was discovered.

• Brand Name: PAGEWRITER TC50 CARDIOGRAPH
• Common Device Name: PAGEWRITER TC50 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• MDR Report Key: 11824535
• Report Number: 1218950-2021-10539
• Device Sequence Number: 4367045
• Product Code: DPS
• UDI-Device Identifier: 00884838026568
• UDI-Public: 00884838026568
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K080999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• 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
• Operator of Device: Health Professional
• Device Model Number: 860310
• Device Catalogue Number: 860310
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/30/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1