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

Model Number 3301

Device Problem Data Problem (3196)

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

Event Type  malfunction  

Event Description

It was reported that the device won't register data, but it turns on.Patient involvement is unknown.

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.

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 Description

Additional information received: there is no patient involvement and no patient or clinical injury.The outcome was resolved.

• 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: 17905291
• MDR Text Key: 325294011
• Report Number: 3012307300-2023-09146
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 30843418000849
• UDI-Public: 30843418000849
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943404
• 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

• Date FDA Received: 10/10/2023
• 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: 3301A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1