MAUDE Adverse Event Report: ST PAUL BCI OXIMETER SPECTRO2 - WW1000 SERIES

Catalog Number WW1020A1FR

Device Problem Inaccurate Information (4051)

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

Event Type  malfunction  

Manufacturer Narrative

Udi, device serial number/lot number, are unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the discrepancies observed between pulse and saturation values (despite a reliable perfusion score) compared to the patient's clinical condition.Tests were performed with healthy subjects, with warm extremities and protected from light, and same issue observed.No clinical consequence or injury observed reported.

Manufacturer Narrative

Other, other text: b5: describe event or problem: updated with additional information received.D10: device available for evaluation: updated.H3: device evaluated by manufacturer: updated.H4: device manufacture date: updated.H6: event problem and evaluation codes: updated.H10: device evaluation: one oximeter device was returned to manufacturing for investigation.Visual inspection and functional testing were performed.Visual inspection of the returned device confirmed that tamper seals were not implemented by manufacturing.No corrosion or impact damage was present.Error codes or event history log (ehl) are not applicable to this device.An oxygen saturation spo2 test and oximetry probe self-check was performed.The customer reported issue was not confirmed or duplicated as the spo2 test passed on all thresholds via the simulator as well as on the investigator via the probe.The oximetry function is operating within factory specifications.The root cause of the reported issue is unknown as no fault was found.No action was needed for the reported problem since no fault was found.A device history record (dhr) review of job folder 4238003 indicated that the device passed all functional test during manufacturing per test data report form having spo2 and pulse values within specified range.Out of this job of 10, no discrepancy was identified and no failure or rework was recorded.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).

Event Description

Additional information was received by the manufacturer which confirmed that no clinical consequence or injury was observed.

• Brand Name: BCI OXIMETER SPECTRO2 - WW1000 SERIES
• Type of Device: OXIMETER
• 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; minneapolis, MN 55442
• MDR Report Key: 15838187
• MDR Text Key: 307597339
• Report Number: 3012307300-2022-27392
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WW1020A1FR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1