MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3532A; VITAL SIGNS MONITOR

Model Number	BSM-3532A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the unit will inflate the cuff correct pressure, but during the deflation portion the pump does not do anything and does not deflate the cuff.Tech support (ts) asked the customer if the unit give a "module failure" message, and the customer stated that "no.It just sits there not doing anything." not in patient use.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the unit will inflate the cuff correct pressure, but during the deflation portion the pump does not do anything and does not deflate the cuff.Tech support (ts) asked the customer if the unit give a "module failure" message, and the customer stated that "no.It just sits there not doing anything." not in patient use.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.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the nibp pump on the bedside monitor (bsm) would inflate the cuff to the correct pressure, but during deflation, the cuff would not deflate.The bsm did not give an error message.No patient harm or injury was reported.Investigation summary: the customer was to call back with a decision on whether they wanted to send the device in for evaluation, but the customer was unresponsive when nihon kohden technical support (nk ts) tried to follow up with them.Nk was unable to confirm the reported issue nor determine a definitive root cause, due to the limited information provided, as the issue is user dependent, and the device was not returned for evaluation.Potential causes for nibp pump failures are physical damage to the device or its components or use errors.Use errors include the use of incompatible cuffs/hoses/cables, the cuff is wrapped too tightly or loosely, the hose or line is not connected properly, a bent hose, the nibp measurement is performed concurrently with an ibp measurement, or patient conditions such as: body movement, arrhythmia, and/or being under spinal anesthesia during cpr, as a pulse wave is not detectable.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that the nibp pump on the bedside monitor (bsm) would inflate the cuff to the correct pressure, but during deflation, the cuff would not deflate.The bsm did not give an error message.Not in patient use.

• Brand Name: BSM-3532A
• Common Device Name: VITAL SIGNS 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: 13831609
• Report Number: 8030229-2022-02662
• Device Sequence Number: 1468103
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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-3532A
• Device Catalogue Number: BSM-3532A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown