MAUDE Adverse Event Report: ST PAUL MINI TORR NIBP BCI MULTIPARAMETER MONITOR; OXIMETER

Model Number 6004001

Device Problem Insufficient Information (3190)

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

Event Date 12/28/2022

Event Type  malfunction  

Event Description

It was reported that the device gave error code e4 and e20.There has been no report of patient involvement, no observable clinical symptoms, or a change in symptoms identified in the patient.

Manufacturer Narrative

Date of event is unknown.No information has been provided to date.A product sample was received and is awaiting evaluation, 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

B5: additional information received, corrected data: b3, h6 problem patient code.

Event Description

Additional information received via email: the event occurred during testing on (b)(6) 2022.There was no patient/clinical injury.

Manufacturer Narrative

A review of this file determined it to be not reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.File cc-0182278 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: MINI TORR NIBP BCI MULTIPARAMETER MONITOR
• Type of Device: OXIMETER
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16259149
• MDR Text Key: 308360381
• Report Number: 3012307300-2023-00716
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10610586036583
• UDI-Public: 10610586036583
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6004001
• Device Catalogue Number: 6004001
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1