MAUDE Adverse Event Report: ST PAUL BCI BLOOD PRESSURE MONITOR MINI-TORR PLUS - 6004; OXIMETER

Device Problem Device Alarm System (1012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the device is presenting with an error code and it will not turn off.No patient injury was reported.

Manufacturer Narrative

The product was returned for evaluation.The monitor came in for an error message and will not turn off, the customers comments are verified.E-05 error is key being pressed while power up.The keypads ends were cleaned and reseated, and the monitor still would not turn off, so the keypads were replaced and now the monitor responds correctly when all buttons are pushed.Trends have been identified related to this failure mode, where the left keypad will respond intermittently or have shorted keys causing malfunctions.However investigation could not detect the actual cause behind this malfunctions other than the suspected quality and durability of the supplied item.The issue is being monitored through the trend review system for elevated trends, and corrective actions will be taken accordingly.Further device history record (dhr) review is not relevant because the results of the complaint investigation do not indicate a problem with the initial manufacture or prior repair of the device.No information is provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BCI BLOOD PRESSURE MONITOR MINI-TORR PLUS - 6004
• Type of Device: OXIMETER
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15329106
• MDR Text Key: 305385554
• Report Number: 3012307300-2022-17081
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1