MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TC30 CARDIOGRAPH

Model Number 860306

Device Problem Device Emits Odor (1425)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

Customer reported a burning smell.The device was not in use on a patient.

Manufacturer Narrative

E1:phone not provided.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

Customer reported a burning smell and the unit failed to power on.The device was not in use on a patient.

• Brand Name: PAGEWRITER TC30 CARDIOGRAPH
• Type of Device: PAGEWRITER TC30 CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10805213
• MDR Text Key: 216837090
• Report Number: 1218950-2020-06742
• Device Sequence Number: 1
• Product Code: DPS
• UDI-Device Identifier: 00884838081123
• UDI-Public: (01)00884838081123
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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: 860306
• Device Catalogue Number: 860306
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1