MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3552A; VITAL SIGN MONITOR

Model Number BSM-3552A

Device Problem Power Problem (3010)

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

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this bedside monitor (bsm) was making a loud screeching noise after which the unit shut down and reboot itself.At the time, the bedside was displaying a "press f4 to start" error.No harm or injury occurred to the patient.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 Description

The customer reported that this bedside monitor (bsm) was making a loud screeching noise after which the unit shut down and reboot itself.At the time, the bedside was displaying a "press f4 to start" error.No harm or injury occurred to the patient.

Event Description

The customer reported that this bedside monitor (bsm) was making a loud screeching noise, after which the unit shut down then rebooted on its own.The bsm was also displaying a "press f4 to start" error message.No harm or injury occurred to the patient.

Manufacturer Narrative

Details of complaint: the customer reported that this bedside monitor (bsm) was making a loud screeching noise, after which the unit shut down then rebooted on its own.The bsm was also displaying a "press f4 to start" error message.No patient harm or injury was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The customer had reported that the issue was transferred to a different department and that the customer had not received any updates and could not provide additional information.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal similar complaints.Due to the sound reported by the customer, it is likely that the device experienced a form of hardware failure causing the noise and sudden reboot.A hardware failure could come as a result of physical damage, fluid damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Fluid intrusion would result in electrical damage to internal components as well as possible corrosion.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt #1: 04/28/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded, but only requested additional troubleshooting assistance.Attempt #2: 05/17/2022 emailed customer via microsoft outlook for all items under the no information section.The customer replied by stating that the issue was turned over for review to another department.However, the customer never heard back from them.

• Brand Name: BSM-3552A
• Type of Device: 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: 14289137
• MDR Text Key: 291324494
• Report Number: 8030229-2022-02803
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: 04931921113677
• 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: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-3552A
• Device Catalogue Number: BSM-3552A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2020
• 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