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

Model Number	BSM-3572A
Medical Device Problem Codes	Incorrect Measurement (1383); Output Problem (3005)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the bsm displayed inaccurate spo2 and ekg readings while on a patient.No consequence or impact to the patient was reported.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
Event or Problem Description
It was reported that the bsm displayed inaccurate spo2 and ekg readings while on a patient.No consequence or impact to the patient was reported.
Event or Problem Description
It was reported that the bsm displayed inaccurate spo2 and ekg readings while on a patient.No consequence or impact to the patient was reported.
Additional Manufacturer Narrative
Details of complaint: incident aware date: (b)(6) 2019 incident summary: the customer reported that the ecg (electrocardiogram) and the spo2 (oxygen saturation) measurements were inaccurate.Per the onsite biomed, there was no signal loss, but the signals were showing different numeric values for ecg and spo2.The customer did not specify how he interpreted the numerics and determined inaccuracy.He tested the device with a simulator and could not duplicate the issue, so the device was put back in use, and it was operating per specifications.No further issue has been reported.Per the onsite biomed, it was the operator's error.No patient harm was reported.Product id and serial id: bsm-3572a, sn:(b)(6).Service requested: troubleshooting.Service performed: troubleshooting.Investigation summary: the issue could not be duplicated.The nature of the complaint and the root cause of the failure is user error.The severity is determined to be high.Rpn: high disposition of complaint: the inaccuracy could not be duplicated, and the device was working per specifications; therefore, no capa required.

• 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: 8719315
• Report Number: 8030229-2019-00226
• Device Sequence Number: 2090791
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: 04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• Report Date (Section F): 06/20/2019

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: 05/29/2019
• Device Age: 23 MO
• Event Location: Other
• Date Report to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 11/05/2020
• 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: 06/20/2019