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

Model Number	6004001
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event problem and evaluation codes: updated after device evaluation.Device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the on off switch was used to the point the paint came off.The customer stated problem was not duplicated.No fault found with the device regarding the reported customer problem.The cause of the reported problem could not be determined.The dhr review is not applicable or relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.
Event or Problem Description
It was reported that a smiths medical patient monitoring|bci blood pressure monitor mini-torr plus - 6004 unit was not turning on fully.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-04700.The report was submitted in error.

• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13822147
• Report Number: 3012307300-2022-04700
• Device Sequence Number: 16664647
• 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): 05/10/2023

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: 07/29/2021
• 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: 07/26/2021
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2004
• 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