MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6000 SERIES; VITAL SIGNS MONITOR

Model Number BSM-6500A

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device Issue (2379)

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

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the resp rate would fall to zero intermittently on the bedside monitor (bsm).Changing the impedance from rl to rf resolved the issue.

Event Description

The biomedical engineer reported that the resp rate would fall to zero intermittently on the bedside monitor (bsm).

Manufacturer Narrative

H10: additional narrative: (b)(6) reported on (b)(6) 2018 that they were having intermittent zeroing on respiration rate.Service requested: troubleshooting service performed: troubleshooting technical support had the customer change impedance from rl to rf and this resolved the issue.Investigation result(s): respiration is measured and monitored by attaching the ecg electrodes and changes in impedance are measured between the r and f or r and l ecg electrodes.Per page 2.4 of the bsm-6000 user guide, the user is advised to select the optimum positions for both ecg and respiration measurements or measure respiration by the thermistor method.Examples of electrode lead position and corresponding waveforms are provided for the user to reference when optimizing signal acquisition.The root cause of the issue was user error/user education as the customer did not have their impedance properly configured.The customer did not have the correct impedance chosen to optimize waveform and respiration rate acquisition.Changing the impedance method from rl to rf allowed the user to obtain more accurate readings and stop the zeroing.This was not an nk device/software malfunction.The device serial number history for the mu-651ra (sn: (b)(6)) shows that there have been no further/previously reported issues nor servicing for zeroing of respiration rate.The issue is the result of user error and the issue was resolved through changing the impedance method from rl to rf.There is no suspected adverse trend and there is no indication of design deficiency.Investigation by qa has been completed.Corrected information: g4.Date received by manufacturer: should be 03/08/2018 not 04/05/2018 as listed on mdr initial report additional information: b4.Date of this report; d4.Unique identifier (udi) #; 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; h3.Device evaluated by manufacturer?; h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.

Event Description

The biomedical engineer reported that the resp rate would fall to zero intermittently on the bedside monitor (bsm).

• Brand Name: BSM-6000 SERIES
• 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: 7401401
• MDR Text Key: 104538389
• Report Number: 8030229-2018-00099
• Device Sequence Number: 1
• Product Code: MHX
• 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: 07/31/2019

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-6500A
• Device Catalogue Number: MU-651RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Distributor Facility Aware Date: 07/31/2019
• Device Age: 28 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2019
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1