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: HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR
  • 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
 

HEARTSINE TECHNOLOGIES LTD PACKAGE,350P,PP01,EN,350-STR-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number SAM 350P
Medical Device Problem Code Power Problem (3010)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/14/2021
Type of Reportable Event Malfunction
Event or Problem Description
Device will not power on with pad-pak but will when others are used.No patient involvement.
 
Additional Manufacturer Narrative
The returned pad-pak performed to specification throughout testing and would have been capable of delivering shock therapy.The 350p device was not returned to heartsine for investigation and therefore the combination of pad-pak and device could not be tested.H3 other text : incomplete device returned for evaluation.
 
Event or Problem Description
Device will not power on with pad-pak but will when others are used.No patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PACKAGE,350P,PP01,EN,350-STR-US-10
Common Device Name
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
EI  BT3 9ED
MDR Report Key11768707
Report Number3004123209-2021-00135
Device Sequence Number11921052
Product Code MKJ
UDI-Device IdentifierM727SAM350P
UDI-PublicM727SAM350P
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P160008
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 07/21/2021
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 No Information
Device Model NumberSAM 350P
Device Catalogue Number350-STR-US-10
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/14/2021
Supplement Date Received by Manufacturer07/06/2021
Initial Report FDA Received Date05/04/2021
Supplement Report FDA Received Date07/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-