MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1733A; VITAL SIGNS MONITOR

Model Number BSM-1733A

Device Problems Power Problem (3010); Appropriate Term/Code Not Available (3191); Complete Loss of Power (4015)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the patient vitals were not flowing to the emr due to the duplicate bed id which was found.Also, when the transport monitor was undocked from the host bsm, and it powered off.No patient harm was reported.Investigation conclusion: the device logs and eg logs were investigated by nkc.It was determined that the cause of the issue was power failure of the bsm-1700 during wlan transport.The customer later reported on 12/01/2023 under ticket (b)(4) that this unit was unable to charge batteries and that they would repair the device themselves.Possible cause of the power failure is likely hardware component failure which can occur through physical damage or fluid intrusion from user mishandling, electrical damage from outages or surges, or wear-and-tear which depends on device age and frequency of use.The complaint device is 6 years old.Due to the device age, wear-and-tear may be a likely contributing factor to hardware failure.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the bedside monitor.Central nurse's station model: cns-6801a sn: (b)(6) device manufacturer date: 07/20/2017 unique identifier (udi) #: (b)(4) returned to nihon kohden: not returned bedside monitor model: bsm-6701a sn: (b)(6) device manufacturer date: 06/19/2017 unique identifier (udi) #: (b)(4) returned to nihon kohden: not returned.

Event Description

The biomedical engineer (bme) reported that the patient vitals were not flowing to the emr due to the duplicate bed id which was found.Also, when the transport monitor was undocked from the host bsm, and it powered off.No patient harm was reported.

• Brand Name: BSM-1733A
• 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 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18378140
• MDR Text Key: 331379521
• Report Number: 8030229-2023-03944
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: 4931921111833
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-1733A
• Device Catalogue Number: BSM-1733A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2017
• 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
• Treatment: BSM-6701A SN (B)(6); CNS-6801A SN (B)(6)