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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT; AUTOMATED EXTERNAL DEFIBRILLATOR
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HEARTSINE TECHNOLOGIES LTD UNKNOWN_MEDICAL - BELFAST_PRODUCT; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Model Number HDF3500
Device Problem Use of Device Problem (1670)
Patient Problems Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  Death  
Manufacturer Narrative
Heartsine has requested the return of the device for investigation.Upon completion, the conclusions will be submitted in a follow-up report.Heartsine contacted the customer to request additional information on the patient.No response has been received from the customer.The hdf 3500 device is not available for distribution in the united states but is similar to the sam 350p and 450p which is distributed in the united states.
 
Event Description
The distributor contacted heartsine to report that voice prompts stopped during a patient involved event.However, a clinical review of the device download was completed for the reported event and determined that the event occurred due to a user pad placement issue.This event was patient involved and a patient death was reported.However, based on the clinical evaluation there is no indication of a device malfunction that has contributed to the patient outcome.
 
Manufacturer Narrative
Heartsine evaluated the customer's device but was unable to duplicate the reported issue.There was no fault found on the hdf-3500 or returned pad-pak.During the investigation, all audio prompts were delivered clearly and audibly with no omissions.There was no visible damage or abnormalities with the speaker or speaker cable, and there was no measurable fault on the speaker coil.The device delivered the full shock therapy sequence without fault, and accurately measured impedance throughout the specified range, even under the stress of elevated temperature.No continuity issue was identified on the electrode/patient output cables and no fault found on the pogo pins.The investigation can only suggest that the pads had been placed incorrectly or the pad-pak incorrectly seated, resulting in no impedance detection.The device was scrapped by heartsine and the customer was provided with a replacement device.
 
Event Description
The distributor contacted heartsine to report that voice prompts stopped during a patient involved event.However, a clinical review of the device download was completed for the reported event and determined that the event occurred due to a user pad placement issue.This event was patient involved and a patient death was reported.However, based on the clinical evaluation there is no indication of a device malfunction that has contributed to the patient outcome.
 
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Brand Name
UNKNOWN_MEDICAL - BELFAST_PRODUCT
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
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
todd bandy
207 airport road west
belfast BT3 9-ED
EI   BT3 9ED
4258674577
MDR Report Key13951878
MDR Text Key289335424
Report Number3004123209-2022-00048
Device Sequence Number1
Product Code MKJ
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 Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/06/2022
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? Yes
Device Operator Lay User/Patient
Device Model NumberHDF3500
Device Catalogue NumberUNK_BEL
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 03/09/2022
Initial Date FDA Received03/30/2022
Supplement Dates Manufacturer Received06/06/2022
Supplement Dates FDA Received06/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/30/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Death;
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