MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS; ELECTROCARDIOGRAPH

Patient Problem Insufficient Information (4580)

Event Date 06/15/2023

Event Type  malfunction  

Event Description

Ekg machine not working.Delay in care.May have been related to connectivity issues.Machine was checked and no errors were found.

• Brand Name: PHILIPS
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 222 jacobs street; cambridge MA 02140
• MDR Report Key: 18072781
• MDR Text Key: 327394350
• Report Number: 18072781
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2023
• Date Report to Manufacturer: 11/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA