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
Additional Manufacturer Narrative
Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.The suspect device was returned for evaluation.Visual and functional testing were performed.Visual inspection found there was no physical damage or defect noted.Functional testing found that the complaint was confirmed.The root cause of the reported issue was found to be the malfunctioning ear probes.Monitor to return back to germany service center along with accessories except the ear probes.Non conformance report (ncr) request submitted for further investigation into the failure and needed actions for proper disposition of the ear sensors.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 the suspect device was providing incorrect reading.No patient injury was reported.

• 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: 15327089
• Report Number: 3012307300-2022-16978
• Device Sequence Number: 6361623
• 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: Non-Healthcare 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• 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