MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD HEARTSINE SAMARITAN 300P AND PAD PAK; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 04/10/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Not yet returned to manufacturer.

Event Description

A patient involved in this event.Device kept prompting to check pads.

Manufacturer Narrative

(b)(4).Heartsine technologies ltd (manufacturer) is submitting the report on behalf of (b)(4).The device history records for the returned sam 300p device were reviewed and this confirmed that all manufacturing and quality checks and tests had been successfully completed prior to the despatch of the sam 300p from heartsine technologies, belfast on (b)(6) 2007.On receipt of the device the history and memory logs were downloaded.Between the (b)(6) 2014 and the (b)(6) 2017 several record random manual power ups were recorded.On one occasion the device was attached to a patient with an in-range impedance being measured and a 150j shock being successfully delivered.On the (b)(6) 2017, the device was reported as being used in an sca event.Two separate events were recorded.The first event was 3 minutes 43 seconds in duration.The patient impedance was out of range for the duration of this event.The ecg suggests that the patient was presenting p-wave asystole.As the impedance was out of range, the algorithm did not assess the patient's rhythm during this event.Some noise in the ecg signal was seen at 00:02:19 to 00:02:24, and from 00:03:16 to the end of the event.No signal was recorded on the icg trace throughout this event.This may be due to the pad-pak being incorrectly inserted, leading to insufficient pogo-pin contact.The second event was 2 minutes 43 seconds in duration.The patient impedance was out of range for the duration of this event.At 00:00:03, the ecg suggests that the patient was presenting fine ventricular fibrillation.As the impedance was out of range, the algorithm did not assess the patient's rhythm during this event.The patient then presented asystole at 00:00:49 before returning to fine ventricular fibrillation.A cardiac complex was seen at 00:02:11.No signal was recorded on the icg trace throughout this event.This may be due to the pad-pak being incorrectly inserted, leading to insufficient pogo-pin contact.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.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 that occasion, impedances were measured within range throughout the sca and the device successfully entered analysing mode before delivering a 150j shock.

Event Description

A patient was involved in this event.Device kept prompting apply pads.It would not recognise the pads had been applied.

• Brand Name: HEARTSINE SAMARITAN 300P AND PAD PAK
• Type of Device: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; canberra house; 203 airport road west; belfast, northern ireland BT3 9 ED; UK BT3 9ED
• Manufacturer (Section G): HEARTSINE TECHNOLOGIES LTD; canberra house; 203 airport road west; belfast, northern ireland BT3 9 ED; UK BT3 9ED
• Manufacturer Contact: james mcguinness ; canberra house; 203 airport road west; belfast, northern ireland BT3 9-ED ; UK BT3 9ED ; 4289093941
• MDR Report Key: 6574703
• MDR Text Key: 77541516
• Report Number: 3004123209-2017-00458
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K041067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/04/2017,06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SAM
• Device Catalogue Number: 300P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2017
• Device Age: 10 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/04/2017
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-0124-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Death