MAUDE Adverse Event Report: ST PAUL BCI SMITHS MEDICAL SPECTRO2 PULSE OXIMETER

Model Number	WW1000A1EN
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suspect device was providing incorrect reading.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated that all inspections were completed and the manufacturing process at the manufacturing facility and the suspect device manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.The suspect device was returned for evaluation.Physical and functional testing was performed and found that the issue was an out of box failure.Several tests were performed including; connecting the suspect device to a known good testing probe and the reported issue was duplicated and confirmed.Further evaluation determined that when flapping the clips constantly in an open and closed movement, the advisor monitor consistently detects and displays a heart rate.Evidence of noise interfering with the emitter and the detector signal which contributed to the customer's observed failure of erratic and erroneous readings.Concluded that the detector in the suspected device may have been malfunctioning all this time.However, there was no difference in the form and fit of the returned suspect device as alleged by the customer.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI SMITHS MEDICAL SPECTRO2 PULSE OXIMETER
• 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; minneapolis, MN 55442
• MDR Report Key: 15326568
• Report Number: 3012307300-2022-16915
• Device Sequence Number: 6484414
• Product Code: DQA
• UDI-Device Identifier: 30843418000283
• UDI-Public: 30843418000283
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2022

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
• Operator of Device: Health Professional
• Device Model Number: WW1000A1EN
• Device Catalogue Number: WW1000A1EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown