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

Model Number	6004001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
B5: additional information received, corrected data: b3, h6 problem patient code.
Event or Problem Description
Additional information received via email: the event occurred during testing on (b)(6) 2022.There was no patient/clinical injury.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2023-00716
• Device Sequence Number: 4779149
• Product Code: DQA
• UDI-Device Identifier: 10610586036583
• UDI-Public: 10610586036583
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K031742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 03/01/2023; 03/24/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 03/10/2023; 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown