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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITOR SYSTEM
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ZOLL MANUFACTURING CORPORATION UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITOR SYSTEM Back to Search Results
Model Number UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 04/22/2024
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces.
 
Event Description
A us distributor contacted zoll to report that the patient developed a skin irritation from the ucor hfams patch.Patient described the area as red and stinging under the patch adhesive.There was no alleged device malfunction contributing to the irritation.The patient's physician recommended temporary removal of the patch due to the skin irritation.Outcome of the skin irritation is unknown.
 
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Brand Name
UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM
Type of Device
MANAGEMENT AND MONITOR SYSTEM
Manufacturer (Section D)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA
Manufacturer Contact
zoll mfg corporation
121 gamma drive
pittsburgh, PA 15238
MDR Report Key19172552
MDR Text Key340919110
Report Number3008642652-2024-04256
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K172510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM
Initial Date Manufacturer Received 04/24/2024
Initial Date FDA Received04/24/2024
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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