MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6300A; VITAL SIGNS MONITOR

Model Number BSM-6300A

Device Problems Device Alarm System (1012); False Alarm (1013); Device Stops Intermittently (1599); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their bedside monitor (bsm) will randomly alarm and then reboot itself.The customer states the issue will randomly occur and he doesn't know what the alarm is because the bsm reboots itself before he can get into the room.He verified the power cable and ups were working properly.Customer sent the unit in for repair.The unit was cleaned and evaluated.The reported problem of "randomly alarm and then reboot itself" was duplicated.All malfunctioning parts were replaced.The unit was tested per operator's/service manual and completed 24 hours of extended testing.The unit operates to manufacturer's specifications.

Event Description

The customer reported that their bedside monitor (bsm) will randomly alarm and then reboot itself.

Event Description

The customer reported that their bedside monitor (bsm) will randomly alarm and then reboot itself.

Manufacturer Narrative

Details of the complaint on (b)(6) 2018, customer at (b)(6) hospital reported the bsm-6300a (mu-631ra sn:(b)(4) would randomly alarm and reboot itself.He verified the power cable and ups were working/good.Service requested repair service performed the unit was cleaned and evaluated.The reported problem of "randomly alarm and then reboot itself" was duplicated.All malfunctioning parts were replaced.The unit was tested per operator's/service manual and completed 24 hours of extended testing.The unit operates to manufacturer [?]s specifications.Ur-39450 main digital board, mu-631ra investigation result the bsm warranty began 04/27/16.The reported issue occurred after approximately 22 months at user facility.Per nkc dhr (attached), the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.Review of device sap history found no previously reported issues with the unit.Evaluation of the unit at nka confirmed the reported issue.Review of similar tickets using keywords "mu-631ra" with "reboot" or "spontaneous" found: (1) 45671/300151660 reported 11/29/18: device spontaneously rebooted.Customer was advised the batteries were well above the charge cycle limit.This is not related to the current issue investigated.(2) 43974/300149937 reported 11/07/18: device was randomly rebooting and going into communication loss.This was an out of box failure.(3) 57091/300167865 reported 04/22/19: device shut down during use and rebooted.Irc-nka300175773 was opened on 08/09/19 to investigate a similar incidence in which (mu-631ra sn:(b)(4) was reported to spontaneously power down and reboot.Per nkc engineering, there is no tendency of the ur-39450 main board failure in japan.The root cause of the main board failure could not be determined from the information available.No adverse trend suspected at this time.The main digital board #ur-39450 was replaced to resolve the issue and the bsm was operating within specifications after repair.The bsm was returned to the customer on (b)(6) 2018 and there were no further reported issues with the unit.Additional information: b4.Date of this report f6.Date user facility/importer became aware of the event f7.Type of report f11.Date report sent to fda f13.Date report sent to manufacturer g4.Date received by manufacturer g7.Type of report h2.If follow-up, what type? additional information device evaluation h3.Device evaluated by manufacturer h6.Event problem and evaluation codes h10.Additional manufacturer narrative the following fields are not applicable (n/a) to this report: a2 - a6 b2 b6 b7 d4 lot # & expiration date d6 - d7 d9 d11& c2 f10 g6 g8 h7 h9.

• Brand Name: BSM-6300A
• 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: 7539052
• MDR Text Key: 109110827
• Report Number: 8030229-2018-00170
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BSM-6300A
• Device Catalogue Number: MU-631RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2019
• Distributor Facility Aware Date: 10/04/2019
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2019
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1