MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6301A; VITAL SIGNS MONITOR

Model Number BSM-6301A

Device Problems Electrical /Electronic Property Problem (1198); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the bedside monitor (mu-631ra) randomly shut down on its own for about 30 seconds and then booted back up on its own.No consequence or impact to the patient.The customer is requesting a repair with loaner.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.

Event Description

The customer reported the bedside monitor (mu-631ra) randomly shut down on its own for about 30 seconds and then booted back up on its own.

Event Description

The customer reported the bedside monitor (mu-631ra) randomly shut down on its own for about 30 seconds and then booted back up on its own.

Manufacturer Narrative

Details of complaint: on 02/11/2020, customer at union general hospital reported that the monitor randomly shut down on its own.The bsm (mu-631ra, sn # (b)(4) ) would work fine for some time but then shut off without user intervention.When it shut down, it usually turned off for about 30 seconds then booted back up on its own.Service requested: repair.Service performed: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.The reported problem of "unit randomly shutdowns and turn of for 30 seconds and then boots back on" was duplicated.The evaluation found there was physical damage to the front and rear enclosures.Nk repair center (warranty) replaced all the malfunctioning parts.The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.Investigation summary: root cause of the issue was identified to be customer abuse.Warranty of device was valid till 11/26/2020.The reported issue is not suspected to be caused by a deficiency or non-conformance of the nk device and no risk assessment is performed.

• Brand Name: BSM-6301A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 9759621
• MDR Text Key: 204412957
• Report Number: 8030229-2020-00114
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: 04931921103517
• Combination Product (y/n): N
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

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-6301A
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2020
• Distributor Facility Aware Date: 05/01/2020
• Device Age: 56 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2020
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1