MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9100A

Device Problem Intermittent Communication Failure (4038)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the unit is having intermittent signal loss and wants someone to go on site.The customer was not interested in troubleshooting the problem, just wants someone to visit the site to look at the reported issue.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.Attempt # 1: 04/19/2021 emailed the customer via microsoft outlook for patient information: the customer replied by simply stating; i would not be able to get the patient information, nor can i release patient information.Attempt # 2: 04/19/2021 emailed the customer via microsoft outlook for patient information: the customer replied by simply stating; i would not be able to get the patient information, nor can i release patient information.Attempt # 3: 04/19/2021 emailed the customer via microsoft outlook for patient information: the customer replied by simply stating; i would not be able to get the patient information, nor can i release patient information.Additional model information: concomitant medical device: the following device was used in conjunction with the cns: orgs: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Event Description

The customer reported that the unit (org) is having intermittent signal loss.

• Brand Name: ORG-9100A
• Type of Device: MULTIPLE PATIENT RECEIVER
• 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: 11704431
• MDR Text Key: 269595903
• Report Number: 2080783-2021-00243
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• 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: 04/21/2021
• Distributor Facility Aware Date: 03/23/2021
• Device Age: 60 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1