MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER TRIM III CARDIOGRAPH

Model Number 860286

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Misdiagnosis (2159)

Event Type  malfunction  

Event Description

The customer reported the device was misdiagnosing patients.No patient harm was reported.

Manufacturer Narrative

(b)(4).A f/u report will be submitted upon completion of the investigation.

• Brand Name: PAGEWRITER TRIM III CARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: greg theokas ; 3000 minuteman rd.; andover, MA 01810 ; 9786871501
• MDR Report Key: 3905142
• MDR Text Key: 4652333
• Report Number: 1218950-2014-03178
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2014

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: 860286
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2008
• 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