MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 450P, PP03J, JA 450-BAS-JA-08; AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	SAM 450P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Connection fail between gateway and sam 450p.No patient involvement.

• Brand Name: PACKAGE, 450P, PP03J, JA 450-BAS-JA-08
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): HEARTSINE TECHNOLOGIES LTD; 203 airport road west; belfast BT3 9 ED; EI BT3 9ED
• MDR Report Key: 11213522
• Report Number: 3004123209-2021-00021
• Device Sequence Number: 3581409
• Product Code: MKJ
• UDI-Device Identifier: M727SAM450P
• UDI-Public: M727SAM450P
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

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: 450-BAS-JA-08
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1