MAUDE Adverse Event Report: ST PAUL BCI; BLOOD PRESSURE MONITORING.

Model Number	6004001
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical patient monitoring|bci blood pressure monitor mini-torr plus - 6004 revealed error code 13 indicating leak.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.The tamper seal was removed from the device, and there was no physical damage found.The reported issue was duplicated.The reported complaint was verified after performed nibp test on a live patient and there was an intermittent error code 13.Performed leak test on the returned product with a fluke and passed.However, the error code 13 wound randomly appear during random nibp testing.The main battery would cause the monitor to shut off during the test.The reported complaint was due to a defective main board.The root cause remains undetermined.

• Brand Name: BCI
• Common Device Name: BLOOD PRESSURE MONITORING.
• 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: 12321266
• Report Number: 3012307300-2021-08417
• Device Sequence Number: 17270110
• Product Code: DQA
• UDI-Device Identifier: 10610586036583
• UDI-Public: 10610586036583
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2008
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown