MAUDE Adverse Event Report: ST PAUL BCI SPECTRO2 10 PULSE OXIMETER

Model Number	WW1000EN
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Operator of device and initial reporter sent to fda are unknown; no additional information was received.The device was returned for first-time service and evaluation after 2 years in the field.The strain relief section of the ear probe was found damaged.Investigation determined that the strain relief device connection end of the spo2 probe was torn and open internal wires connection were detected.The open wires resulted from torn strain relief at the probe connection end due to cord being subject to heavy use with extraneous forces.Instructions for use (ifus) indicate that "misuse or improper handling can damage the sensor or the cable.This may cause inaccurate readings.Do not twist unnecessarily or use excessive force when using, connecting, disconnecting, or storing the sensor." the failure resulted from malfunctioning spo2 probe due to broken internal wire connection.Root cause was deemed to be user interface.A device history record (dhr) review is not applicable in this case because the defective spo2 probe is not evaluated or tested in any way during the manufacturing process and the spo2 probe manufacturing records are retained by the supplier at their manufacturing site and are not readily available for review.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 device was displaying error message when probe is attached.No patient injury was reported.

• Brand Name: BCI SPECTRO2 10 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: 15326490
• Report Number: 3012307300-2022-16909
• Device Sequence Number: 12383329
• Product Code: DQA
• UDI-Device Identifier: 30843418000016
• UDI-Public: 30843418000016
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K083787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• 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
• Device Model Number: WW1000EN
• Device Catalogue Number: WW1000EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• 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
• 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