MAUDE Adverse Event Report: ST PAUL BCI; OXMIETER

Model Number 1303

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

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

Event Type  malfunction  

Event Description

Information received a smiths medical patient monitoring|bci oximeter disposables reported sensors show defects after 1 to 2 days in use.Customer stated they do not dissipate, provide incorrect measure values and the cables of new sensors are already exposed as missing cable covers.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device used.The customer stated problem was duplicated.The cause of the reported problem could not be determined.

• Brand Name: BCI
• Type of Device: OXMIETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12294088
• MDR Text Key: 265593675
• Report Number: 3012307300-2021-08214
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 15019517042511
• UDI-Public: 15019517042511
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K920082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1303
• Device Catalogue Number: 1303
• Device Lot Number: 1952-8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1