MAUDE Adverse Event Report: ACCRIVA DIAGNOSTICS HOLDINGS, INC. AVOXIMETER WHOLE BLOOD OXIMETER

Model Number	C100B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
When attempting to check hemoglobin during cardiac cath unable to insert blood into cuvette.Nurse met resistance so cuvette was unusable manufacturer response for cuvette- whole blood oximeter, avox (per site reporter).Credited account for 2 boxes.

• Brand Name: AVOXIMETER WHOLE BLOOD OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS HOLDINGS, INC.; 6260 sequence dr; san diego CA 92121
• MDR Report Key: 8572613
• Report Number: 8572613
• Device Sequence Number: 16599637
• Product Code: DQA
• UDI-Device Identifier: 10711234160022
• UDI-Public: (01)10711234160022
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2019
• Report Date (Section F): 04/30/2019

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: Health Professional
• Device Model Number: C100B
• Device Catalogue Number: C100B
• Device Lot Number: 812-109
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/30/2019