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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR
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ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2023
Event Type  malfunction  
Event Description
During the preventive maintenance (pm) on (b)(6), 2023, the backlight of the autopulse platform (sn (b)(6)) flickers briefly when switched on and is dark afterwards, and the battery icon on the display was not readable.No patient involvement.
 
Manufacturer Narrative
During the preventive maintenance (pm) on (b)(6), 2023, the backlight of the autopulse platform (sn (b)(6)) flickers briefly when switched on and is dark afterwards, and the battery icon on the display was not readable.The root cause of the reported complaint was a lc display failure, likely attributed to the age of the device.The autopulse platform was manufactured in 2013 and is 10 years old, past the expected serviceable life of five years.Upon visual inspection, the backlight of the display flickers briefly when switched on and is dark afterwards.In addition, the battery icon on the display was not readable.The lc display will be replaced to address the observed issue.The power distribution board revision is up to date.The brake gap was within specification.The autopulse platform passed the initial functional testing without any fault or error.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints for autopulse platform with sn (b)(6).
 
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Brand Name
AUTOPULSE® RESUSCITATION MODEL 100
Type of Device
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION INC
2000 ringwood ave
san jose CA
Manufacturer (Section G)
ZOLL CIRCULATION INC
2000 ringwood ave
san jose CA 95131
Manufacturer Contact
kim thoa nguyen
2000 ringwood ave
san jose, CA 95131
4084192922
MDR Report Key17782062
MDR Text Key323848835
Report Number3010617000-2023-00834
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0740-08
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2013
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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