MAUDE Adverse Event Report: Q CORE MEDICAL LTD. MINI CRADLE

Model Number	15042-000-0010
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The compliant was reported by a customer from (b)(6).Mini cradle issue.
Event or Problem Description
The compliant was reported by a customer from italy.Mini cradle issue.

• Brand Name: MINI CRADLE
• Common Device Name: MINI CRADLE
• Manufacturer (Section D): Q CORE MEDICAL LTD.; yad harutzim 29 st.; netanya, 42505 29; IS 4250529
• MDR Report Key: 10828737
• Report Number: 3010293992-2020-00047
• Device Sequence Number: 3048904
• Product Code: MRZ
• UDI-Device Identifier: 17290109150045
• UDI-Public: 17290109150045
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

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: Other
• Device Model Number: 15042-000-0010
• Device Catalogue Number: 15042-000-0010
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1