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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITOR SYSTEM
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ZOLL MANUFACTURING CORPORATION ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITOR SYSTEM Back to Search Results
Model Number ARRHYTHMIA MANAGEMENT SYSTEM
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Localized Skin Lesion (4542)
Event Date 08/06/2023
Event Type  Injury  
Event Description
Zoll laboratory services contacted zoll to report that a patient developed a broken skin irritation under the patch.Patient described the area as red and itchy.There was no alleged device malfunction contributing to the irritation.The patient's physician recommended removal of the patch and prescribed a cream for the skin irritation.Outcome of the irritation is unknown.
 
Manufacturer Narrative
Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces.
 
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Brand Name
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 Key17650372
MDR Text Key322280439
Report Number3008642652-2023-08681
Device Sequence Number1
Product Code MHX
Combination Product (y/n)N
PMA/PMN Number
K190939
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/30/2023
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 NumberARRHYTHMIA MANAGEMENT SYSTEM
Initial Date Manufacturer Received 08/08/2023
Initial Date FDA Received08/30/2023
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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