Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY Back to Search Results
Model Number MODEL 100
Medical Device Problem Code Battery Problem (2885)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 01/09/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse lithium ion battery for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
 
Event or Problem Description
During a shift check, it was reported that the autopulse platform displayed a message of "replace/recharge battery; empty battery symbol" after a fully charged autopulse lithium ion battery (b)(4) was inserted.The reporter indicated that the battery had 4 green leds lit.According to the reporter, the issue was replicated several times with multiple platforms.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AUTOPULSE® LI-ION BATTERY
Common Device Name
LI-ION BATTERY
Manufacturer (Section D)
ZOLL CIRCULATION
2000 ringwood ave.
san jose CA 95131
MDR Report Key6302039
Report Number3010617000-2017-00097
Device Sequence Number13588390
Product Code DRM
UDI-Device Identifier00849111002059
UDI-Public00849111002059
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K112998
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberMODEL 100
Device Catalogue Number8700-0702-01
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/09/2017
Initial Report FDA Received Date02/03/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-