MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI 3301 HAND HELD PULSE OXIMETER

Model Number	3301A3
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the device takes a long time to register on oxygen (o2); "if it registers one at all".Patient involvement is unknown.
Event or Problem Description
Additional information received via email.There was no patient involvement and no patient or clinical injury.The outcome was resolved.
Additional Manufacturer Narrative
Health impact, and evaluation codes: updated.No product was returned, and no photographic evidence was provided to aid in the investigation.As a result, a complaint investigation, product evaluation and problem confirmation cannot be performed.The exact cause could not be determined.However, the most probable cause was a faulty main board or spo2 probe/spo2 cable.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Additional Manufacturer Narrative
D4 was corrected.Udi related data quality updates only.

• Brand Name: BCI 3301 HAND HELD PULSE OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 17905410
• Report Number: 3012307300-2023-09154
• Device Sequence Number: 7897365
• Product Code: DQA
• UDI-Device Identifier: 30843418001099
• UDI-Public: (01)30843418001099(11)191223(21)000006568
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K020739
• 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): 10/26/2023

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: 3301A3
• Device Catalogue Number: 3301A3
• 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: 12/23/2019
• 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