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

Catalog Number UNK_BEL

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This was a patient involved event.A resident participating in therapy became light headed and hypotensive with blood pressure 60/40 and had a palpable pulse.The pads were applied and the device was turned on.During the event the device instructions allegedly stopped at "place the patches on the patient".A minute passed and the patches were removed and hands on cpr was started.The battery pack is dated 2021-09-01.The pads were sticky and were placed on the chest.There was little hair present.The patient survived to hospital admission.

• Brand Name: HEARTSINE SAMARITAN 300P AND PAD-PAK
• Type of Device: AUTOMATED 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 Key: 7887558
• MDR Text Key: 120732944
• Report Number: 3004123209-2018-00581
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_BEL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0124-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization