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

Model Number 3301

Device Problem Failure to Sense (1559)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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 Description

Additional information received via email.There was no patient involvement and no patient or clinical injury.The outcome was resolved.

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.

• Brand Name: BCI 3301 HAND HELD PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17905410
• MDR Text Key: 325295308
• Report Number: 3012307300-2023-09154
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418001099
• UDI-Public: 30843418001099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 3301
• Device Catalogue Number: 3301A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1