MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; VITAL SIGNS MONITOR

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the nurse noticed that the ac cradle was hot to the touch and took the unit out of service.It was not charging the bsm-1700s being placed in it, and the internal pcb board looked burned.The bedside monitor itself was not returned, but the sc-170r ac cradle used with the bedside monitor was returned.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 device information: concomitant medical device: the following devices were being used in conjunction with bsm unit and was the unit that failed: ac cradle: model: sc-170r, sn: (b)(4).Device manufacturer date: 02/05/2016.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: 05/03/2022.

Event Description

The biomedical engineer (bme) reported that the nurse noticed that the ac cradle was hot to the touch and took the unit out of service.It was not charging the bsm-1700s being placed in it, and the internal pcb board looked burned.The bedside monitor itself was not returned, but the sc-170r ac cradle used with the bedside monitor was returned.Not in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the ac cradle was hot to the touch, and it was no longer charging the bsm-1700s.The internal pcb board looked burned.The sc-170r ac cradle was returned for an exchange, but no bsms were returned.The device was not in patient use.Investigation summary: during the evaluation of the reported device, nihon kohden repair center (nk rc) confirmed the reported complaint and found that the unit was unrepairable.The customer reported that the pcb board for the device was found to be burned.Some common reasons for a pcb board burnout include: overheating: excessive heat can cause the pcb to burn.This can happen if the electronic components on the board generate more heat than the board or its cooling system can dissipate.Overheating can lead to component failure and damage to the pcb.Overcurrent or short circuits: high current levels beyond the rated capacity of the pcb or unexpected short circuits can cause excessive current flow, leading to overheating and burning.This can be caused by faulty components, damaged traces, or incorrect wiring.Voltage spikes: sudden spikes in voltage, often caused by power surges or electrical faults, can overwhelm the protective features of the pcb and cause components to burn.Component failure: individual electronic components on the pcb, such as resistors, capacitors, or integrated circuits, can fail due to manufacturing defects, wear and tear, or exposure to conditions beyond their specifications.A failed component may generate excessive heat and cause the pcb to burn.Environmental factors: exposure to extreme environmental conditions, such as high humidity, corrosive substances, or contaminants, can degrade the pcb's materials over time, potentially leading to burnout.Improper handling: rough handling during assembly, maintenance, or transportation can cause physical damage to the pcb, including broken traces or damaged components, which can contribute to burnout.Moisture and water damage: exposure to moisture or water can cause short circuits and corrosion on the pcb, leading to burnout.Water damage can be especially problematic because it can create conductive paths where they shouldn't exist.Aging: over time, the materials used in the pcb can degrade, and solder joints may develop hairline cracks.This aging process can increase the risk of burnout.Attempt #1 04/18/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details and only the model series number (bsm-1700 series), but did not provide all the requested information.Additional device information: d10: concomitant medical device: the following device, which is the device that experienced the falure and was returned to nk, was used in conjunction with the bsm unit: ac cradle model: sc-170r.Sn: (b)(6).Device manufacturer date: 02/05/2016.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: 05/03/2022.

Event Description

The biomedical engineer (bme) reported that the ac cradle was hot to the touch, and it was no longer charging the bsm-1700s.The internal pcb board looked burned.The sc-170r ac cradle was returned for an exchange.The device was not in patient use.

• Brand Name: NI
• 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 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: 14312569
• MDR Text Key: 299757603
• Report Number: 8030229-2022-02833
• Device Sequence Number: 1
• Product Code: MHX
• 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,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: SC-170R SN (B)(6); SC-170R SN (B)(6)