MAUDE Adverse Event Report: ST PAUL BCI 3301 HAND HELD PULSE OXIMETER

Model Number	3301
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device won't register data, but it turns on.Patient involvement is unknown.
Additional Manufacturer Narrative
Other, other text: b3: date of event is unknown, no 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.
Additional Manufacturer Narrative
Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The most probable cause is a malfunctioning main board or spo2 probe/spo2 cable.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history report (dhr) review could not be completed as the dhr is housed at the supplier.
Event or Problem Description
Additional information received: there is no patient involvement and no patient or clinical injury.The outcome was resolved.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: BCI 3301 HAND HELD PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 17905291
• Report Number: 3012307300-2023-09146
• Device Sequence Number: 12652484
• Product Code: DQA
• UDI-Device Identifier: 30843418000849
• UDI-Public: (01)30843418000849(11)230111(21)000010012
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K943404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2024

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: 3301
• Device Catalogue Number: 3301A1
• 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: 08/31/2023
• Supplement Date Received by Manufacturer: 09/29/2023; Not provided
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 10/26/2023; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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