Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
MAUDE Adverse Event Report:; ELECTROCARDIOGRAM
FDA Home
Medical Devices
Databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
; ELECTROCARDIOGRAM
Back to Search Results
Device Problem
Device Alarm System (1012)
Patient Problem
Irregular Pulse (2469)
Event Date
04/25/2015
Event Type
malfunction
Event Description
A patient had a long heart pause of 6 seconds, the monitor technician did not call for this.When the rn called to find out why he did not call, the tech said that the alarms did not go off.
Search Alerts/Recalls
New Search
|
Submit an Adverse Event Report
Type of Device
ELECTROCARDIOGRAM
MDR Report Key
4973095
MDR Text Key
6336675
Report Number
4973095
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
Type of Report
Initial
Report Date
06/18/2015
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
Was Device Available for Evaluation?
Yes
Was the Report Sent to FDA?
Yes
Date Report Sent to FDA
06/19/2015
Event Location
Hospital
Date Report to Manufacturer
08/05/2015
Initial Date Manufacturer Received
Not provided
Initial Date FDA Received
06/19/2015
Patient Sequence Number
1
Patient Age
93 YR
-
-