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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION, INC AUTOPULSE® RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR

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ZOLL CIRCULATION, INC AUTOPULSE® RESUSCITATION SYSTEM MODEL 100; CARDIAC CHEST COMPRESSOR Back to Search Results
Model Number MODEL 100
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104); Complaint, Ill-Defined (2331)
Event Type  Injury  
Event Description
Complainant alleged that after a recent call it was observed that a male patient was bleeding from his chest.The injury was initially described as two puncture marks, which were located under the "puck" (electrodes) of the defibrillator pads.It was suggested that the patient's 5 year old cardiac surgery scar, had opened in two places.Manual cpr was performed for 6 minutes.No error codes were shown.No further information was provided.Please note that the event date is unknown.Manufacturer has made several attempts to obtain additional information, however no further information has been provided.
 
Manufacturer Narrative
Customer also reported that they saved the lifeband as well as the cpr stat pads from this incident.Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
 
Manufacturer Narrative
The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform shows no damages.A review of the autopulse archive was performed and no issues were observed on the reported event date.Functional testing was performed and the platform passed the initial system test.The load cell characterization was performed and it indicated that both load cells are functioning as intended.The platform was run with a 95% patient test fixture with known good batteries for several hours.No faults or errors were observed.Based on the investigation, no parts were identified for replacement.In summary, the platform was evaluated through functional testing and the platform passed all testing criteria.
 
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Brand Name
AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
Type of Device
CARDIAC CHEST COMPRESSOR
Manufacturer (Section D)
ZOLL CIRCULATION, INC
2000 ringwood ave.
san jose CA 95131
Manufacturer (Section G)
ZOLL CIRCULATION, INC
2000 ringwood ave.
san jose CA 95131
Manufacturer Contact
joy patel
2000 ringwood ave,
san jose, CA 95131
4084192957
MDR Report Key3978129
MDR Text Key21806135
Report Number3003793491-2014-00382
Device Sequence Number1
Product Code DRM
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K112998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 07/08/2014
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 Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0700-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/19/2014
Initial Date FDA Received08/04/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/04/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
MANUAL CPR; AUTOPULSE® LIFEBAND, CHEST COMPRESSION ASSEMBLY,; DEFIBRILLATION PADS
Patient Outcome(s) Other;
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