MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC50 CARDIOGRAPH

Model Number 860310

Device Problem Device Fell (4014)

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

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.Reporting address state: (b)(6).

Event Description

The customer reported that the device had fallen and was very damaged; the rear cover is damaged, some screws have been lost, and the power supply connecting has been damaged as well.It is unknown if the device was in clinical use at the time the device fell.There was no adverse event or patient harm reported.It was unknown if the fall was an accidently drop, or if the device fell due to a mounting issue.

Manufacturer Narrative

A request was made to determine the cause of the fall.But no information was provided.The device was operational after repairs were completed.All tests passed as designed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: PAGEWRITER TC50 CARDIOGRAPH
• Type of Device: PAGEWRITER TC50 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18041500
• MDR Text Key: 326990705
• Report Number: 1218950-2023-00829
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00884838026568
• UDI-Public: 00884838026568
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1