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

Model Number BSM-6300A

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Failure to Analyze Signal (1539); Device Stops Intermittently (1599); Device Inoperable (1663)

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

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the bedside monitor (bsm), which was in use with a multigas unit during a procedure, was intermittently shutting down.The pump would stop, the co2 waveform would disappear, and there was no numerical data.The multigas unit was found to be working fine so the bsm was the device responsible for the malfunction.The bsm has been received by nihon kohden repair center and is pending evaluation.The multigas unit will also be evaluated but is on a separate ticket.

Event Description

The biomedical engineer reported that the bedside monitor (bsm), which was in use with a multigas unit during a procedure, was intermittently shutting down.The pump would stop, the co2 waveform would disappear, and there was no numerical data.

Manufacturer Narrative

H10: additional narrative: (b)(6) reported on (b)(6) 2018 that their gf-210ra would intermittently shut down, the pump would stop, and the waveform would disappear for co2.There was no numerical data either.The customer received a loaner gas unit from ticket (b)(4) and the unit was also not working, therefore the bedside was sent in for evaluation (mu-631ra sn: (b)(6)).Service requested: repair/loaner.Service requested: repair/loaner.Mu-631ra/sn-(b)(6) was cleaned and evaluated.The reported problem of "received the loaner gas unit it was also not working." the bedside also came in for evaluation.Through testing, trouble shooting and extended operation of the device, the issue could not be duplicated.The bedside mu-631ra/sn-(b)(6) also tested with on the network with a known good working cns.Review of the device history indicates no previous cnd status.The unit was tested per operator's/service manual.The unit completed 2 days of extended testing and operates to manufacturer's specification.Investigation result(s): the root cause of the issue was unable to be identified due to being unable to duplicate the reported issue.Per the repair center's evaluation, the unit was not having any issues during testing and was performing as intended.The device serial number history shows that there have been no further/previously reported issues nor servicing for this device functioning intermittently.Review of the device history record (dhr) shows that the unit has no history of ncmr, capa, refurbishing, or other suspected defects.Ticket (b)(4) - spontaneous shut down and re-boot reported on (b)(6) 2019.Trending analysis found only one similarly reported issues regarding mu-631ra device shutting down randomly.The other reported issues of pump stopping, co2 waveform disappearing, missing numerical data could not be found within similar tickets.This indicates that the issue is unique to this facility.There is no suspected adverse trend nor indication of design deficiency.Investigation by qe has been completed as investigational information within the record documents that the device was performing as manufacturer intended corrected information: g4.Date received by manufacturer: should be 03/27/2018 not 04/26/2018 as listed on mdr initial report.

Event Description

The biomedical engineer reported that the bedside monitor (bsm), which was in use with a multigas unit during a procedure, was intermittently shutting down.The pump would stop, the co2 waveform would disappear, and there was no numerical data.

• 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: 7465441
• MDR Text Key: 106719759
• Report Number: 8030229-2018-00131
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• 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: 04/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2019
• Distributor Facility Aware Date: 07/17/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2019
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1