MAUDE Adverse Event Report: GE HEALTHCARE MAC 5500; ELECTROCARDIOGRAPH

Model Number MAC 5500

Device Problem Incorrect Measurement (1383)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969)

Event Date 09/10/2016

Event Type  malfunction  

Event Description

Patient arrived to er via ems with complaints of chest pain.Patient diagnosed with stemi and code was called.After code completed, it was discovered that the ekg machine was not properly timed and stamped the code call 3 minutes before it was actually performed.

• Brand Name: MAC 5500
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE HEALTHCARE; 9900 innovation dr.; rp2138; wauwatosa WI 53226
• MDR Report Key: 6089535
• MDR Text Key: 59512843
• Report Number: 6089535
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2016

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: Nurse
• Device Model Number: MAC 5500
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR