MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3572A; VITAL SIGN MONITOR

Model Number	BSM-3572A
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse reported that the bedside monitor was giving a fluttering heart rate.The hr was jumping from 140 to over 200.Testing with a transmitter showed normal hr.They were advised to use new lead sets and cables to resolve the issue.
Event or Problem Description
The nurse reported that the bedside monitor was giving a fluttering heart rate.The hr was jumping from 140 to over 200.
Additional Manufacturer Narrative
Details of the complaint on 07/11/2018, customer at (b)(6) medical center reported the bedside monitor (bsm-3572a sn:(b)(4)) had a patient with a fluttering heart rate (hr) that was jumping from 140 to over 200.The patient was connected to a transmitter with another set of leads and the hr was reading normally.Service requested troubleshooting/assistance.Service performed customer was advised to try new lead sets/cables, and to connect the bsm to a simulator to see if it was getting accurate readings.Multiple attempts were made to follow up with the customer, with no further information provided.Investigation results per nkc dhr, 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.The bsm was delivered to the customer on 02/08/2018.The reported issue occurred after 5 months at customer facility.Review of device sap history found no other issues reported with heart rate.Nka technical support provided customer with troubleshooting steps to resolve the issue and/or confirm if the issue was with the bsm.Similar tickets review using the following keywords found the following: "flutter" 63039/300176412 reported (b)(6) 2019.Root cause was user error/education needed."fluttering" none "hr jump(ed)" none "hr jumping" 4278/300078438 reported (b)(6) 2017.Issue resolved upon changing monitoring settings.Due to the lack of customer response, information is limited and the root cause could not be confirmed.No further issues have been reported against this unit.No adverse trend is suspected for this issue and this issue is not suspected to be caused by deficient design.
Event or Problem Description
The nurse reported that the bedside monitor was giving a fluttering heart rate.The hr was jumping from 140 to over 200.

• Brand Name: BSM-3572A
• Common Device Name: 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: 7772620
• Report Number: 8030229-2018-00301
• Device Sequence Number: 1392553
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: 04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019
• Report Date (Section F): 10/23/2019

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
• Operator of Device: Health Professional
• Device Model Number: BSM-3572A
• Device Catalogue Number: BSM-3572A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/22/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 10/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NOT APPLICABLE
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/23/2019