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

Model Number BSM-6300A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reports that the blood pressure readings are inaccurate for the bedside monitor (bsm) system due to the input module ay-653p failing.We asked the biomed for clarification on how the bp readings were inaccurate and if this was in use on a patient and what their status was or if this was found while testing on a simulator.As it is unclear how the blood pressure readings were inaccurate at this point, a report is being filed.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.Concomitant medical devices: input unit ay-653p, sn (b)(4).

Event Description

The biomedical engineer reports that the blood pressure readings are inaccurate for the bedside monitor (bsm) system due to the input module ay-653p failing.

Event Description

The biomedical engineer reports that the blood pressure readings are inaccurate for the bedside monitor (bsm) system due to the input module ay-653p failing.

Manufacturer Narrative

Details of complaint: the customer reported the input unit, ay-653p-qm connected to a bedside monitor (bsm) was showing nibp readings that were inaccurate.The customer did not provide further information.Attempts to follow up with the customer were made, but there was no response.Service requested / performed: troubleshooting.Investigation summary: the root cause of this issue cannot be determined as there was not enough information provided from the customer.Attempts were made to follow up with the customer, but there was no response.There was no further information provided and due to the age of this complaint, no additional information can be obtained from the customer.Since the root cause was unable to be determined, no capa is required.Without a root cause, the counter measure to prevent recurrence cannot be performed.The overall risk rating is medium.The following fields are not applicable (na) to the mdr report: d4 lot # & expiration date g4 device bla number the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the input unit: bsm: model #: bsm-6000 series additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative corrected information: corrected the fields below to reflect that the device was not returned to the manufacturer.D9 device available for evaluation? h3 device evaluated by manufacturer?.

• Brand Name: BSM-6300A
• Type of Device: VITAL SIGNS MONITOR
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 8736931
• MDR Text Key: 149494660
• Report Number: 8030229-2019-00243
• 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: 06/26/2019,07/20/2021

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-6300A
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2019
• Distributor Facility Aware Date: 06/05/2019
• Device Age: 86 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AY-653P SN (B)(6); AY-653P SN (B)(6)