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

Catalog Number 3301A1

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that the doctors and nurses are giving patients low spo2 in the 80 and when they send the patient to the emergency room, they get a call from the emergency room stating the spo2 was 93.There was a patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

B3: date of event is unknown.No information has been provided to date.H3: other; device not returned to manufacturer.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.

• Brand Name: BCI 3301 HAND HELD PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18945730
• MDR Text Key: 338250051
• Report Number: 3012307300-2024-01516
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3301A1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1