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

Catalog Number	WW1030EN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that there was a numerical abnormality.The event occurred during patient use, and unknown patient harm/adverse event reported.
Additional Manufacturer Narrative
H3 and h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection noted no abnormalities in the appearance of the product.The customer's reported problem, there was a numerical abnormality, was not verified by functional testing.The complaint was not confirmed.The cause is presumed to be a malfunction in the sensor probe that was being used at the same time.No repairs required.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The device passed all functional tests after repair.

• Brand Name: BCI
• Common Device Name: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18539800
• Report Number: 2183161-2024-00074
• Device Sequence Number: 12379395
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: 30843418000191
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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 Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/28/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown