MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A; RECEIVER UNIT

Model Number ORG-9700A

Device Problems Application Program Problem (2880); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that they are having an issue with the arrythmia recall where it was showing with the incorrect date, (b)(6) 1970.Arrhythmia recall is historical arrythmia data on the central nurse's station (cns).The customer confirmed that all the real time alarms are reporting correctly.The customer uses arrhythmia recall to print strips, and this is needed when there is an abnormal rhythm so that the doctors and cardiologists can view them.This impacts patient care.Nihon kohden technical support (tech support) informed them that this was a multiple patient receiver (org) issue that was ongoing.No patient harm reported.Attempt #1: (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: (b)(6) 2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Concomitant medical device: the following device(s) were being used in conjunction with the org, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Multiple patient receiver: model: org-9700a.Sn: (b)(4).Approximate age of device: 206 months.Device manufacturer date: 12/15/2003.Unique identifier (udi) #: na.Returned to nihon kohden: not returned.Central nurse's station.Model: cns-9701a.Sn: ni.Telemetry transmitters.Model: ni.Sn: ni.

Event Description

The biomedical engineer reported that they are having an issue with the arrythmia recall where it was showing with the incorrect date, (b)(6) 1970.Arrhythmia recall is historical arrythmia data on the central nurse's station (cns).The customer confirmed that all the real time alarms are reporting correctly.The customer uses arrhythmia recall to print strips, and this is needed when there is an abnormal rhythm so that the doctors and cardiologists can view them.This impacts patient care.Nihon kohden technical support (tech support) informed them that this was a multiple patient receiver (org) issue that was ongoing.No patient harm reported.

• Brand Name: ORG-9700A
• Type of Device: RECEIVER UNIT
• 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: 11572018
• MDR Text Key: 242705188
• Report Number: 2080783-2021-00168
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9700A
• Device Catalogue Number: MU-970RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2021
• Distributor Facility Aware Date: 02/23/2021
• Device Age: 206 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1