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

Device Problem Output Problem (3005)

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

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they experienced pulse oximeter failure in two separate rooms.The customer also reported that they mitigated this issue by transferring data and recycling power.No patient harm or injury has been reported.This complaint was created to document the hospital department logs.The hospital will not be providing any additional information.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, model name, catalog name, serial number, unique identifier (udi) number, concomitant medical products.Approximate age of the device.No serial number was provided, so the age of the device is unknown.Pma/510(k) number, device manufacturer date.

Event Description

The customer reported that they experienced pulse oximeter failure in two separate rooms.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019 customer submitted the log entry from the facility stating that "(b)(6) room 514 and 526 pulse/ox failure.Had to transfer data and recycle power to resolve.(we would like to know why this happens)" customer stated they could not provide any information regarding the entry note.Investigation summary due to the lack of information available, an investigation into the reported issue is currently not possible.No risk assessment could be performed.F9 approximate age of the device.No serial number was provided, so the age of the device is unknown.

Event Description

The customer reported that they experienced pulse oximeter failure in two separate rooms.

• 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: 9533651
• MDR Text Key: 182569678
• Report Number: 8030229-2019-00756
• 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: 06/25/2020

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: 06/25/2020
• Distributor Facility Aware Date: 06/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2020
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 06/23/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1