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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
Catalog Number UNK_BEL
Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 04/01/2018
Event Type  Death  
Manufacturer Narrative
Exemption number (b)(4). Heartsine technologies ltd (manufacturer) is submitting the report on (b)(4). Not returned yet.
 
Event Description
During a car accident in (b)(6), the patient suffered a sudden cardiac arrest. The fire brigade rescuers connected the aed to the patient. Cardiopulmonary resuscitation was undertaken. The device commands stopped and looped "press the electrodes firmly against the chest". The patient's chest was dry and shaved. The patient did not survive.
 
Manufacturer Narrative
The device history record for the sam 300p device was reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed. No rework was conducted. The sam 300p passed ¿out qat from heartsine technologies on the (b)(6) 2007. Three events were recorded in the devices memory log. On (b)(6) 2017 06:59:36 the event was 20 minutes 28 seconds in duration. The pads were initially adhered at 00:01:07. The patient presented pulseless electrical activity (pea) and there was some high frequency noise in the icg trace. The device prompted the user to perform chest compressions at 00:01:25, and a ¿pads off¿ prompt was sounded at 00:01:25. The ¿pads on¿ and ¿pads off¿ prompts continued until the device was switched off. The patient remained in pea throughout the event, and the high frequency noise in the icg was also visible throughout the event. On (b)(6) 2017 16:31:36 the event was 9 minutes 37 seconds in duration. The pads were placed 2 minutes 25 seconds after the pads were placed. The patient presented asystole and a shock was not advised. Chest compressions were delivered at an average rate of 192 compressions per minute. The patient remained asystolic and a shock was not advised. Chest compressions continued at an average rate of 192 compressions per minute. The patient remained asystolic and a shock was not advised. Chest compressions continued at an average rate of 186 compressions per minute until the aed was switched off. On (b)(4) 2018 16:38:45 the event was 4 minutes in duration. The device prompted the user to apply the pads throughout. There is some signal in the ecg trace from 00:00:59 to 00:03:50, but it is unknown if this is cardiac in nature. The memory log showed that at no time during the reported sca had the device detected an in range patient impedance. This meant that the device did not progress beyond the advisory speech prompts of apply pads to patient's bare chest as shown in picture. During the investigation, the device was found to be correctly measuring impedance throughout the range even under the stress of elevated temperature. The reported fault may have been because of poorly placed electrode pads or an incorrectly installed pad-pak. This conclusion is further supported by the device performing to specification, when previously attached to a patient on the (b)(6) 2017. On that occasion, impedances were measured within range throughout the sca and the device successfully entered analysing mode before advising no shock. This device shall by retained by heartsine as per complaint handling procedure (b)(4).
 
Event Description
During a car accident in poland , the patient suffered a sudden cardiac arrest. The fire brigade rescuers connected the aed to the patient. Cardiopulmonary resuscitation was undertaken. The device commands stopped and looped "press the electrodes firmly against the chest". The patient's chest was dry and shaved. The patient did not survive.
 
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Brand NameUNKNOWN_MEDICAL - BELFAST_PRODUCT
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
Manufacturer (Section G)
HEARTSINE TECHNOLOGIES LTD
203 airport road west
belfast BT3 9 ED
Manufacturer Contact
caroline kirwan
203 airport road west
belfast BT3 9-ED
2890939400
MDR Report Key7442436
MDR Text Key105875928
Report Number3004123209-2018-00274
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K014067
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_BEL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location Other
Date Manufacturer Received05/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0124-2013

Patient Treatment Data
Date Received: 04/19/2018 Patient Sequence Number: 1
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