MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3572A; VITAL SIGN MONITOR

Model Number	BSM-3572A
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported that the bedside monitor (bsm) mounted onto the wall in one of their emergency rooms (er) is having trouble with taking an accurate blood pressure.The blood pressure readings is off when compared to what the nurses are getting with a manual blood pressure, example of inaccurate readings are 188/100, but the reading should be 135/80.There are no error messages on the screen of the bsm.The nurse reports that they use a new blood pressure cuff with each patient and that the issue still occurs.The nurse states that the device was making a loud sound while inflating the blood pressure cuff.No patient harm reported.Nihon kohden has received the device for inspection.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
Event or Problem Description
The nurse reported that the bedside monitor (bsm) mounted onto the wall in one of their emergency rooms (er) is having trouble with taking an accurate blood pressure.The blood pressure readings is off when compared to what the nurses are getting with a manual blood pressure, example of inaccurate readings is 188/100, but the reading should be 135/80.There were no error messages on the screen of the bsm.The nurse reports that they use a new blood pressure cuff with each patient and that the issue still occurs.The device was making a loud sound while inflating the blood pressure cuff.No patient harm reported.Nihon kohden has received the device for inspection.
Event or Problem Description
The nurse reported that the bedside monitor (bsm) in one of their emergency rooms (er) was not taking an accurate blood pressure reading and was making a loud sound during cuff inflation.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the nurse reported that the bedside monitor (bsm) in one of their emergency rooms (er) was not taking an accurate blood pressure reading and was making a loud sound during cuff inflation.The blood pressure readings were off when compared to what the nurses were getting with a manual blood pressure.An example of the inaccurate readings is 188/100, but the reading should have been 135/80.There were no error messages displayed at the bsm.No patient harm or injury was reported.Investigation summary: the customer sent the device in for evaluation.During the device evaluation, nihon kohden (nk) was able to confirm the reported issue was due to physical damage, as the front enclosure had damage and the pump, and the pump components were damaged/malfunctioning and needed replacing.During a review of the complaint device history and facility trending it was determined that this was an isolated incident, as this was the only complaint found for this device and facility in the past 3 (three) years.As such, a significant trend that would warrant any action and/or any corrective action was not identified.There is no evidence of an nk device malfunction.Attempt # 1: 03/09/2022 emailed the customer via microsoft outlook for the required information in the ni list above: a reply was received by the customer who stated there were no other devices contributing to the blood pressure issue, only the bedside monitor itself, and they were not able to provide any patient demographics as the issue occurred on multiple patients.

• Brand Name: BSM-3572A
• Common Device Name: VITAL SIGN MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13792273
• Report Number: 8030229-2022-02651
• Device Sequence Number: 1633011
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: 04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: BSM-3572A
• Device Catalogue Number: BSM-3572A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown