MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS; APPARATUS, AUTOTRANSFUSION

Model Number 3600

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/05/2015

Event Type  malfunction  

Event Description

Pt had a pulse ox of 81% on the monitor.The arterial blood gas (abg) test done at that time had a saturation level of 95.4%.Fifty-five minutes later, the pt had a pulse ox of 63% on the monitor.The abg test done at that time had a sat of 78.4%.Pt had an emergent bronchoscopy started about an hour later that resulted in the pt saturation levels on the monitor dropping to 70%.The pt was bagged by the radiology technician (rt) and md with a bag equipped with a peep valve.Saturation levels continued to drop and the 2 rns changed the pulse ox cable, and the probe from the ear sensor to a regular finger sensor on the right hand to regular sensor on the left hand.Then a pediatric sensor placed on the right hand obtained a poor pleth and a saturation level of 70%.An abg test done then had an o2 saturation level of 100%.Rt also obtained an independent pulse ox box and it would not pick up a saturation level or pleth from any site on the pt.

• Brand Name: OASIS
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson, NH 03051
• MDR Report Key: 5152063
• MDR Text Key: 28319250
• Report Number: 5152063
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 3600
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 65