MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL OXIMETER SPECTRO2

Catalog Number	WW1000EN
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One oximeter was returned for evaluation.Visual inspection of the device found it to be in good physical condition.The device underwent functional testing by testing the spo2 on the simulator, confirming the reported customer complaint.No spo2 readings were present as a result of the test.Further visual inspection found that the oximeter board had come loose due to impact suffered to the monitor.The board was reseated as a preventive measure and now all reading are steady and accurate with several probes and the simulator.The cause of issue was determined to be user interface; no intrinsic evidence to suggest a cause of issue related to manufacturing.
Event or Problem Description
Information was received that a smiths medical sleep capnograph has error sr.It was reported unit was found on shelf; it failed annual inspection.No patient involvement.

• Brand Name: SMITHS MEDICAL OXIMETER SPECTRO2
• Common Device Name: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9181909
• Report Number: 3012307300-2019-05532
• Device Sequence Number: 17054546
• Product Code: DQA
• UDI-Device Identifier: 30843418000016
• UDI-Public: 30843418000016
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K083787
• 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): 10/09/2019

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: No Information
• Device Catalogue Number: WW1000EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1