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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, PRODUCT CODE MHX

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ZOLL MANUFACTURING CORPORATION ARRHYTHMIA MANAGEMENT SYSTEM; MANAGEMENT AND MONITOR SYSTEM, PRODUCT CODE MHX Back to Search Results
Model Number Patch
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 07/21/2021
Event Type  Injury  
Manufacturer Narrative
Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces.
 
Event Description
A zoll laboratory services contacted zoll to report that a patient was bleeding under the patch.There was no alleged device malfunction contributing to the irritation.Outcome of the rash is unknown.
 
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Brand Name
ARRHYTHMIA MANAGEMENT SYSTEM
Type of Device
MANAGEMENT AND MONITOR SYSTEM, PRODUCT CODE MHX
Manufacturer (Section D)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238 3495
Manufacturer (Section G)
ZOLL MANUFACTURING CORPORATION
121 gamma drive
pittsburgh PA 15238 3495
Manufacturer Contact
kevin chan
121 gamma drive
pittsburgh, PA 15238-3495
4129683333
MDR Report Key12308141
MDR Text Key266146883
Report Number3008642652-2021-06955
Device Sequence Number1
Product Code MHX
UDI-Device Identifier00855778005258
UDI-Public00855778005258
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190939
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 08/11/2021
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 NumberPatch
Device Catalogue Number10A1067
Initial Date Manufacturer Received 07/22/2021
Initial Date FDA Received08/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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