MAUDE Adverse Event Report: ST PAUL BCI SPECTRO2 20 PULSE OXIMETER; DQA

Model Number	WW1020EN
Medical Device Problem Codes	Image Display Error/Artifact (1304); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a bci spectro2 20 is showing sr err.No additional information.
Event or Problem Description
It was reported that a bci spectro2 20 is showing sr err.No additional information.
Additional Manufacturer Narrative
Other, other text: a 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 product or photographic evidence were provided to aid in this investigation.As a result, a complaint investigation, product evaluation and problem confirmation cannot be performed.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, this complaint will be reopened for further investigation.E4 is unknown, no information provided to date.
Additional Manufacturer Narrative
Other text: no product was returned by the customer.As a result, a complaint investigation / product evaluation and problem confirmation cannot be performed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: BCI SPECTRO2 20 PULSE OXIMETER
• Common Device Name: DQA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; beaver business park, beaver r; minneapolis, MN 55442
• MDR Report Key: 13585222
• Report Number: 3012307300-2022-03949
• Device Sequence Number: 20254135
• Product Code: DQA
• UDI-Device Identifier: 30843418000108
• UDI-Public: 30843418000108
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2022

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: WW1020EN
• Device Catalogue Number: WW1020EN
• Was Device Available for Evaluation?: No
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 09/07/2022; 10/05/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 10/04/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2013
• 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