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

Model Number C100B

Device Problems Difficult to Insert (1316); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2019

Event Type  malfunction  

Event 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
• Type of Device: OXIMETER
• Manufacturer (Section D): ACCRIVA DIAGNOSTICS HOLDINGS, INC.; 6260 sequence dr; san diego CA 92121
• MDR Report Key: 8572613
• MDR Text Key: 143812315
• Report Number: 8572613
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10711234160022
• UDI-Public: (01)10711234160022
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C100B
• Device Catalogue Number: C100B
• Device Lot Number: 812-109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1