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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL MEDICAL CORPORATION M SERIES BIPHASIC; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
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ZOLL MEDICAL CORPORATION M SERIES BIPHASIC; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) Back to Search Results
Model Number 30001003101110012
Device Problems Low Audible Alarm (1016); Alarm Not Visible (1022); Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2019
Event Type  malfunction  
Event Description
The low battery message does not remain on the screen and is easily missed.The low battery audible alert is the same or similar to the tone of the patient's heart rate.The volume of low battery audible alert is easily missed, as it is the same volume as the heart rate tone.Users suggest the manufacturer improve the low battery message on the screen as well as the audible alert.Suggest the audible alert speak to say: "low battery" and the "low battery" message remain on the screen until a/c power is connected.
 
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Brand Name
M SERIES BIPHASIC
Type of Device
PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Manufacturer (Section D)
ZOLL MEDICAL CORPORATION
269 mill road
chelmsford MA 01824
MDR Report Key8934663
MDR Text Key155644445
Report Number8934663
Device Sequence Number1
Product Code DRO
UDI-Device Identifier00847946017392
UDI-Public(01)00847946017392
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number30001003101110012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/20/2019
Device Age20 MO
Event Location Hospital
Date Report to Manufacturer08/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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