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 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the bedside monitor (bsm) input unit's non-invasive blood pressure (nibp) pump was inflating all the way to "180," but would not deflate.There was no patient harm reported.After the customer saw that the module continued to pump above "200," he immediately turned it off to avoid further malfunction.The customer sent the unit in for a repair.A loaner device was shipped to the customer in the meantime.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.Model number, catalog number, serial 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: 77 months, device manufacturer date: 08/07/2013, unique identifier (udi) #: (b)(4).

Event Description

The customer reported that the bedside monitor (bsm) input unit's non-invasive blood pressure (nibp) pump was inflating all the way to "180," but would not deflate.There was no patient harm reported.

Manufacturer Narrative

Details of the complaint on (b)(6) 2020, customer at (b)(6) reported the input box (ay-653p-qm sn: (b)(6).Would pump up and would not stop.Service requested repair service performed repair investigation conclusion the input box is used in conjunction with the bsm-6000 series bedside monitor.Per bsm-6000 series service manual, if periodic inspection is not performed, degradation or loss of function may go unnoticed and lead to misdiagnosis.It is recommended periodic inspection be performed at least once every year.Customer's maintenance information for this unit is not available.The root cause of the nibp air leak is determined to be failure of the nibp pump #532149b due to blockage and cracking diaphragm.The recommended action under irc-nka300083020 was to replace the pump.The overall risk, as determined from the product of probability (likely) and severity (insignificant), is determined to be medium.The following fields are not applicable (na) to this report: a2 - a6 b2 b6 b7 d4 lot # & expiration date d6 - d7 d9 f10 g6 g8 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: d1 brand name was listed as bsm as the brand name was not provided.D4 model number catalog number serial number unique identifier (udi) # f9 approximate age of device.No serial number was provided, so the age of the device is unknown.G5 pma/510(k) number h4 device manufacture date 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: 77 months device manufacturer date: 08/07/2013 unique identifier (udi) #: (b)(4) additional information: b4.Date of this report d10: device available for evaluation? f6.Date user facility/importer became aware of the event f7.Type of report f11.Date report sent to fda f13.Date report sent to manufacturer g4.Date received by manufacturer g7.Type of report h2.If follow-up, what type? h3.Device evaluated by manufacturer? h6.Event problem and evaluation codes h10.Additional manufacturer narrative.

Event Description

The customer reported that the bedside monitor (bsm) input unit's non-invasive blood pressure (nibp) pump was inflating all the way to "180," but would not deflate.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: 9703269
• MDR Text Key: 204418017
• Report Number: 8030229-2020-00085
• 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: 03/13/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2020
• Distributor Facility Aware Date: 03/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2020
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AY-653P; AY-653P