MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 350P, PP03J, JA, 350-BAS-JA-08; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number SAM350P

Device Problem Unable to Obtain Readings (1516)

Patient Problem Arrhythmia (1721)

Event Date 05/10/2022

Event Type  Death  

Manufacturer Narrative

Heartsine contacted the customer to request additional information on the patient.The customer provided heartsine with the available patient information.Patient fields in which information is not provided were intentionally left blank.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 stryker to report that their device did not start ecg analysis, resulting in the rescue team not knowing if defibrillation was needed.The patient associated with the reported event did not survive.

Manufacturer Narrative

Heartsine evaluated the customer's device but was unable to duplicate the reported issue.No fault was found on the sam 350p or returned pad-pak during the investigation.The device was found to be accurately measure impedance throughout the specified.No continuity issue was identified on the patient output cables and no fault found on the pogo pins that would have resulted in an impedance detection issue.The device delivered the full shock therapy sequence without fault using the returned pad-pak pak and the device recorded ecg data accurately without noise or other abnormalities.The investigation can only suggest that the reported complaint was due to situational factors.E.G., a pad-pak fitment issue or incorrect placement of pads on the patient.The device was scrapped by heartsine.

Event Description

The customer contacted stryker to report that their device did not start ecg analysis, resulting in the rescue team not knowing if defibrillation was needed.The patient associated with the reported event did not survive.

• Brand Name: PACKAGE, 350P, PP03J, JA, 350-BAS-JA-08
• 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 Key: 14596702
• MDR Text Key: 293302056
• Report Number: 3004123209-2022-00080
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

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 Number: SAM350P
• Device Catalogue Number: 350-BAS-JA-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Sex: Male