MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; VITAL SIGNS MONITOR

Device Problem Pumping Problem (3016)

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

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the bedside monitor's (bsm's) non-invasive blood pressure (nibp) cuff would pump up but would not "bleed down" or produce an nibp reading.The customer tried using new cuffs and hoses but had no success.There was no error message displayed on the screen.The unit was in patient use at the time the issue was discovered.Nihon kohden technical support (nk ts) advised that the customer send the unit in for repair and sent the customer a loaner device.Nk ts has not yet received the defective device.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: brand name was listed as bsm as the brand name was not provided.Serial number, catalog number, unique identifier (udi) #.Approximate age of device.No serial number was provided, so the age of the device is unknown.Pma/510(k) number, device manufacture date.Additional device information: the following device was used in conjunction with the bsm and was the device that experienced the failure.Input box: model #: ay-653p, sn #: (b)(4), approximate age of the device: 76 months, device manufacturer date: 08/09/2013, unique identifier (udi) #: (b)(4).

Event Description

The customer reported that the bedside monitor's (bsm's) non-invasive blood pressure (nibp) cuff would pump up, but would not "bleed down" or produce an nibp reading.There was no patient harm reported.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6) medical center reported nibp issues on ay-653p-qm with serial# (b)(6).Service requested: assistance in troubleshooting.Service performed: customer informed that the issue occurred during patients use, the unit would not release pressure once it pumps up.No harm to the patients was reported at the time of incident.Customer tried new cuffs and hoses but the nibp still won't produce a reading and there was no error message displayed on the screen.Nkts requested customer to send the unit in for repair at repair center.Investigation conclusion: root cause of the issue was identified to be hardware failure due to following defective parts: pump and vibration damping sponge.The warranty of unit expired on 03/21/2019.According to the table in quality complaint investigations work instruction, with document id: sop06-075, the risk priority of the issue is categorized as: high conclusion: since risk priority of the issue is categorized as: high.Monitoring of this issue will be continued, and the ticket will be updated once more conclusive information is available.Additional device information: d11 & c2 the following device was used in conjunction with the bsm and was the device that experienced the failure.Input box.Model #: ay-653p.Sn #: (b)(6).Approximate age of the device: 76 months.Device manufacturer date: 08/09/2013.Unique identifier (udi) #: (b)(4).

Event Description

The customer reported that the bedside monitor's (bsm's) non-invasive blood pressure (nibp) cuff would pump up, but would not "bleed down" or produce an nibp reading.There was no patient harm reported.

• Brand Name: NI
• 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: 9599305
• MDR Text Key: 194809797
• Report Number: 8030229-2020-00038
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2020
• Distributor Facility Aware Date: 02/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2020
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AY-653P; AY-653P