MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PAGEWRITER; ELECTROCARDIOGRAPH

Model Number TC70

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

Intermittently, there are "no rhythm" warnings on the monitor during a case.Biomed was called and the monitor generally worked properly on their ecg simulator.Several times, new leads were ordered.At one point there was a hard no rhythm failure on the one unit and continued intermittent activity on the other.There were 2 units.

• Brand Name: PAGEWRITER
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810 109
• MDR Report Key: 4029868
• MDR Text Key: 4799205
• Report Number: 4029868
• Device Sequence Number: 1
• Product Code: DPS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: TC70
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2014
• Device Age: 20 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES