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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION M SERIES; DEFIBRILLATOR/PACEMAKER
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ZOLL MEDICAL CORPORATION M SERIES; DEFIBRILLATOR/PACEMAKER Back to Search Results
Model Number MSERIES CCT
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
 
Event Description
Complainant alleged that during biomed testing, the device was unable to adjust pacer rate.Complainant indicated that there was no patient involvement in the reported malfunction.
 
Manufacturer Narrative
The reported malfunction was observed and attributed to a faulty control switch on the control board.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
 
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Brand Name
M SERIES
Type of Device
DEFIBRILLATOR/PACEMAKER
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
Manufacturer Contact
269 mill road
chelmsford, MA 01824
9784219552
MDR Report Key8338929
MDR Text Key136123911
Report Number1220908-2019-00292
Device Sequence Number1
Product Code DRO
UDI-Device Identifier00847946006501
UDI-Public00847946006501
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011865
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/24/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMSERIES CCT
Device Catalogue NumberM SERIES
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2002
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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