MAUDE Adverse Event Report: ST PAUL BCI OXIMETRY EAR SENSOR; OXIMETER

Model Number	WW3078
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample was received to perform an investigation.A visual inspection of the sensor probe found no physical damage.The returned sensor probe was tested on a live patient using a good known test monitor and the probe was reading properly.The reported problem was unable to be duplicated.The device history record (dhr) was unable to be reviewed as this is a supplied item.No root cause could be determined as the complaint could not be confirmed.D5 is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that during a hospital pre-use check, the customer noticed that the oxygen saturation (spo2) value was unable to be measured correctly by the ear probe.It was suspected that a wire break occurred in the product.No patient injury was reported.

• Brand Name: BCI OXIMETRY EAR SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 4-1-5, izumi-chuo, izumi-ku,; minneapolis, MN 55442
• MDR Report Key: 15422882
• Report Number: 3012307300-2022-19207
• Device Sequence Number: 14622578
• Product Code: DQA
• UDI-Device Identifier: 30843418001099
• UDI-Public: 30843418001099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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
• Device Model Number: WW3078
• Device Catalogue Number: WW3078
• Device Lot Number: 1909-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown