MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1773A; BEDSIDE MONITOR, NK SPO2

Model Number	BSM-1773A
Medical Device Problem Codes	Pressure Problem (3012); Pumping Problem (3016)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the bedside monitor's (bsm) non-invasive blood pressure (nibp) pump was sometimes going to "40" and kept pumping (the cuff would not deflate).The customer also reported that the pump sometimes generated a reading, and other times generated an "air leak error" message.The history log was blank and there were no signs of fluid intrusion or physical damage.The customer sent the unit in for repair under warranty.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.
Event or Problem Description
The customer reported that the bedside monitor's (bsm) non-invasive blood pressure (nibp) pump was sometimes going to "40" and kept pumping (the cuff would not deflate).The customer also reported that the pump sometimes generated a reading, and other times generated an "air leak error" message.
Event or Problem Description
The customer reported that the bedside monitor's (bsm) non-invasive blood pressure (nibp) pump was sometimes going to "40" and kept pumping (the cuff would not deflate).The customer also reported that the pump sometimes generated a reading, and other times generated an "air leak error" message.
Additional Manufacturer Narrative
Complaint information: on (b)(6) 2019, customer at (b)(6) reported sometimes the pressure goes to 40 and keeps pumping.Sometimes it generates a reading.Other times it generates an air leak error.History log blank.No signs of fluid intrusion or physical damage on bsm-1733a with serial# (b)(6).Service requested: warranty repair.Service performed: nkts requested customer to send the unit to repair center for repair.Repair center could duplicate the issue.The unit was cleaned and decontaminated.The model, serial number and all labels were verified.There was no evidence of physical damage and reported issue of nibp air leak was duplicated.The issue was identified to be electronic failure due to failure of pump and vibration damping sponge.All the malfunctioning parts were replaced.The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 24 hours of extended testing and operated to the manufacturer's specifications.Investigation result: root cause of the issue is determined to be failure of the nibp pump #532149b due to blockage and cracking diaphragm.Manufacturer's investigation of the pump failure has been completed.The action recommended by nkc is to replace the pump.Pump functionality is a regular inspection item and the part is replaceable.Warranty of the device is valid till 08/29/2023.Review of ay-653p nibp pump #532149b replacements by year suggests a decreasing trend of pump failures since 2016.

• Brand Name: BSM-1773A
• Common Device Name: BEDSIDE MONITOR, NK SPO2
• 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: 9583808
• Report Number: 8030229-2020-00026
• Device Sequence Number: 3244120
• Product Code: MHX
• UDI-Device Identifier: 04931921111956
• UDI-Public: 4931921111956
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020
• Report Date (Section F): 03/31/2020

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-1773A
• Device Catalogue Number: BSM-1773A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/26/2020
• Device Age: 24 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/31/2020