MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD OB CO#1310451,PKG,450P,PP01,EN,450-BAC-US-10; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	SAM 450P
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2015058.(b)(4).
Event or Problem Description
Device failed to save an event on (b)(6) 2020.Patient involved event, no impact on the patient.

• Brand Name: OB CO#1310451,PKG,450P,PP01,EN,450-BAC-US-10
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; IE BT3 9ED
• MDR Report Key: 9985537
• Report Number: 3004123209-2020-00100
• Device Sequence Number: 3699852
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: SAM 450P
• Device Catalogue Number: 80515-000002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1