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

Model Number WW1020EN

Device Problems Image Display Error/Artifact (1304); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that a bci spectro2 20 is showing sr err.No additional information.

Event Description

It was reported that a bci spectro2 20 is showing sr err.No additional information.

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.

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
• Type of Device: 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
• MDR Text Key: 286013695
• Report Number: 3012307300-2022-03949
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000108
• UDI-Public: 30843418000108
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1