MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1753A; VITAL SIGNS MONITOR

Model Number BSM-1753A

Device Problem Pumping Problem (3016)

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

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their bedside monitor (bsm) nibp cuff is not deflating.No harm or injury was reported.They will be sending this unit in for a repair.Nihon kohden continues to investigate the reported event.

Event Description

The customer reported that their bedside monitor (bsm) nibp cuff is not deflating.

Event Description

The customer reported that the nibp cuff on the bedside monitor (bsm) was not deflating.

Manufacturer Narrative

Details of complaint: the customer reported that the nibp cuff on the bedside monitor (bsm) was not deflating.They sent the unit in for evaluation.No patient harm or injury was reported.Investigation summary: the device was evaluated at nihon kohden america (nka).The reported issue was duplicated.No internal damages were observed.External observations: the handle was missing two screws and the battery cover.The following components were replaced to repair the device: 0010 battery cover bsm-1700 qty 1 0020 bolts hexagon qty 1 (2) 0030 battery pack qty 1 0040 pump assembly, bsm-1700 qty 1 0050 tds-2xv05b-701, bsm-1700 (solenoid) qty 1.The evaluation and servicing information above provides inconclusive details about the cause of the deflation failure.This unit was installed on 4/29/2017 with no prior history of nibp failure.It is presumed that normal wear and tear of the nibp component caused the deflation failure as described in irc-nka300155567.The exact cause could not be determined.Service history for this serial number shows this is an isolated incident.Nibp failure is caused by a number of factors.Examples of these failure include: device damage/broken components: damaged buttons on the control panel, a broken red nibp socket, or physical damage impacting internal components (pump, dpu, power bd, digital bd).Incompatible cuff/hose.Wear and tear of the nibp components: nibp circuit failure, pump failure, or a stuck solenoid.Use error such as: a cuff is wrapped too tightly or loosely, a hose or line is not connected properly, a bent hose, or the nibp is performed concurrently with an ibp measurement.Patient conditions such as: body movement, an arrhythmia, under spinal anesthesia, during cpr, pulse wave is not detectable, or during the use of esu.Analysis of failures under irc-nka300155567 in 2019 shows no tendency of failure in those individual incidents.Pump failures observed were caused by normal wear and tear.When that occurs, the pump and related component(s) should be replaced.

• Brand Name: BSM-1753A
• Type of Device: 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 CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 161-8 560; JA 161-8560
• 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: 11294711
• MDR Text Key: 238628367
• Report Number: 8030229-2021-00057
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921111871
• UDI-Public: 4931921111871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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
• Device Operator: Health Professional
• Device Model Number: BSM-1753A
• Device Catalogue Number: BSM-1753A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1