MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6701A; VITAL SIGN MONITOR

Model Number BSM-6701A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 04/03/2023

Event Type  malfunction  

Event Description

The customer reported that this bedside monitor is flickering/completely going dark intermittently.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this bedside monitor is flickering/completely going dark intermittently.According to the customer, he has not been able to duplicate the issue; however, the nurses reported that this has happened a few times already.The customer wants to send in the unit to be repaired.Technical support (ts) advised the customer that given that they haven't been able to duplicate the issue, this unit may be returned to them as could not duplicate (cnd).There was no patient injury reported.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided:.

Manufacturer Narrative

Details of complaint: the customer reported that this bedside monitor is flickering/completely going dark intermittently.According to the customer, he has not been able to duplicate the issue; however, the nurses reported that this has happened a few times already.The customer wants to send in the unit to be repaired.Technical support (ts) advised the customer that given that they haven't been able to duplicate the issue, this unit may be returned to them as could not duplicate (cnd).There was no patient injury reported.Investigation summary: the nk repair center received the device and found that the lcd had many dead pixels and damage on the rear and front enclosure.Components for the display and casing were replaced to complete the repair.Manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported that this bedside monitor is flickering/completely going dark intermittently.There was no patient injury reported.

• Brand Name: BSM-6701A
• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16857188
• MDR Text Key: 314917480
• Report Number: 8030229-2023-03498
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: 04931921103562
• 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: 08/01/2023

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
• Device Operator: Health Professional
• Device Model Number: BSM-6701A
• Device Catalogue Number: MU-671RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2012
• 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