MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS ELECTROCARDIOGRAPH

Model Number 860315

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/29/2020

Event Type  Malfunction  

Event Description

Was attempting to do a stat ecg. Placed stickers on patient, attached leads to stickers as appropriate. The ecg machine did not show valid tracings on the screen. Narrow tracings appeared to flicker and were very unusual. Obtained another ecg machine from main hospital to perform the required ecg.

• Brand Name: PHILIPS
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10024276
• MDR Text Key: 189869646
• Report Number: 10024276
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (Y/N): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 03/24/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/05/2020
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: 860315
• Device Catalogue Number: 860315
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2020
• Event Location: Hospital
• Date Report TO Manufacturer: 05/05/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage