MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6700A; VITAL SIGN MONITOR

Model Number BSM-6700A

Device Problems Loss of Power (1475); Electrical Power Problem (2925); Unintended Application Program Shut Down (4032)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the bedside monitor (bsm) went down after an electrical surge.No consequence or impact to the patient was reported.The reported product was returned and evaluated.Investigation results: the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.The reported problem of "mu-671ra sn- (b)(4) bedside has system error and was not able to boot up to monitor mode" was duplicated.The root caused "the main board was malfunctioned".All the malfunctioning part were replaced.The unit was tested per the operator's/service manual.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.Repair is completed and ready to be shipped back to customer.

Event Description

It was reported that the bedside monitor (bsm) went down after an electrical surge.No consequence or impact to the patient was reported.

Manufacturer Narrative

Details of the complaint on (b)(6)19, thomas bowe at medical center hospital reported an electrical surge switch took out a board on the bsm-6700a (mu-671ra sn:(b)(4)).The unit was reporting a memory card error and would not boot into monitor or diagnostic check mode.Service requested repair service performed the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.* physical evaluation: no physical damage while initial evaluation.(i meant no physical damages outside of the unit) the reported problem of "mu-671ra sn-1676 bedside has system error and was not able to boot up to monitor mode" was duplicated.The root caused "the main board was malfunctioned".We replaced the following parts below and issue is resolved.Ur-39451 main digital board, mu-671 1 ea the unit was tested per the operator's/service manual and the results were recorded on the attached maintenance check sheet.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.Investigation result the device was placed into service on (b)(6)2013, which is almost 6 years prior to the reported issue.A review of device history found previously reported issue: ticket 59317/notification (b)(4) reported (b)(6)2019 in which customer reported the unit would not boot.The bsm attempts to boot into diagnostic check mode but fails with a "system error" error message.The root cause could not be determined due to the lack of customer response and the unit not being returned.Nka evaluation of the bsm confirmed the reported issue.The main digital board #ur-39451 was replaced to resolve the issue.The main digital board is used to perform digital processing and supply power to the overall monitor.Per bsm-6000 series service manual, customer is advised to perform periodic inspection at least once every year to detect degradation or loss of function.Customer reported boot up issues with the unit a month prior but further details, including troubleshooting and maintenance actions taken, is unknown.It is unknown if this issue contributed or is related to the reported issue.Customer reported there was an electrical surge which caused the board to fail.The root cause is determined to be power issues at the facility.The bsm was able to notify user of issue with error message.Troubleshooting and replacement of the main digital board is addressed in the bsm-6000 series service manual.The part was replaced and the unit was tested to operate within specifications.The repaired unit was returned to the customer on 06/24/19 and there were no further reported issues.The unit was in use with a patient and there was no reported patient harm.Based on the given information, this issue is not suspected to be caused by deficient design and the complaint record will be closed.Corrected information: f9.Approximate age of device: incorrectly calcuated 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, correction, 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.

Event Description

It was reported that the bedside monitor (bsm) went down after an electrical surge.No consequence or impact to the patient was reported.

• Brand Name: BSM-6700A
• Type of Device: VITAL SIGN 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: 8732878
• MDR Text Key: 149248846
• Report Number: 8030229-2019-00239
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: 04931921103562
• 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: 08/29/2019

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-6700A
• Device Catalogue Number: MU-671RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2019
• Distributor Facility Aware Date: 07/03/2019
• Device Age: 76 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1