MAUDE Adverse Event Report: ST PAUL BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER

Model Number	6004001
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical patient monitoring|bci blood pressure monitor mini-torr plus - 6004 has error codes 4,20.No patient adverse event reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The device was built before tamper seal was implemented.There was no physical damage on the device.The technician powered on off the unit and changed parts.The reported issue was confirmed after power on the returned 6004001 monitor with error code e-04 and error 20.The technician measured the coin battery with.25voltage (v) (spec:3v).What caused the reported (primary) problem: the root cause of the reported issue was found to be drained coin battery due to wear.The technician replaced coin battery.Additional heic this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No causes or potential causes of the customer's reported problem were found during the review of service and repair records.A product sample was received for evaluation.Visual and functional testing were performed.The device was built before tamper seal was implemented.There was no physical damage on the device.The technician powered on off the unit and changed parts.The reported issue was confirmed after power on the returned 6004001 monitor with error code e-04 and error 20.The technician measured the coin battery with.25voltage (v) (spec:3v).What caused the reported (primary) problem: the root cause of the reported issue was found to be drained coin battery due to wear.The technician replaced coin battery.

• Brand Name: BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
• 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: 12321702
• Report Number: 3012307300-2021-08420
• Device Sequence Number: 4448008
• 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): 04/12/2023

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: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2010
• 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