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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Event Date 09/19/2022
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces of the lifevest device as well as the blue(tm) defibrillation gel.
 
Event Description
Zoll laboratory services contacted zoll to report that a patient developed a broken, burning skin irritation under the patch adhesive.There was no alleged device malfunction contributing to the irritation.There is no indication that the patient received medical intervention.Outcome of the irritation is unknown.
 
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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 Key15631704
MDR Text Key301992242
Report Number3008642652-2022-24656
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 10/19/2022
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 09/22/2022
Initial Date FDA Received10/19/2022
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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