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,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATORS
  • 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,PP03J,JA,350-STR-JA-10; AUTOMATED EXTERNAL DEFIBRILLATORS Back to Search Results
Model Number 350P
Device Problem Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2023
Event Type  malfunction  
Manufacturer Narrative
Heartsine has requested return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.
 
Event Description
The customer contacted heartsine to report that their device was unable to power on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with this event.
 
Event Description
The customer contacted heartsine to report that their device was unable to power on.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with this event.
 
Manufacturer Narrative
Heartsine evaluated the customer's device and verified the reported issue.Heartsine determined that the cause of the reported issue was due insect inhabitancy within the device.It was observed that multiple insects across the membrane tail which created a high resistance which cause a fault to prohibit the device from powering on.The customer was sent a replacement device and the returned device scrapped by heartsine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PACKAGE, 350P,PP03J,JA,350-STR-JA-10
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
207 airport road west
belfast BT3 9 ED
EI  BT3 9ED
Manufacturer (Section G)
HEARTSINE TECHNOLOGIES LTD
207 airport road west
belfast BT3 9 ED
EI   BT3 9ED
Manufacturer Contact
brian blakeslee
207 airport road west
belfast BT3 9-ED
EI   BT3 9ED
4258674577
MDR Report Key18129954
MDR Text Key328028475
Report Number3004123209-2023-00160
Device Sequence Number1
Product Code NSA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/13/2024
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
Device Operator Lay User/Patient
Device Model Number350P
Device Catalogue Number350-STR-JA-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 11/06/2023
Initial Date FDA Received11/14/2023
Supplement Dates Manufacturer Received02/09/2024
Supplement Dates FDA Received02/13/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-