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.Additional model information: concomitant medical device: the following device was used in conjunction with the 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.

Event Description

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

Manufacturer Narrative

Details of complaint.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.Investigation summary: it was discovered during troubleshooting that the telemetry monitors experiencing signal loss were giving error messages relating to "check leads" and "change batteries".This is an indication that either transmitters were currently being set up or running low on battery power.Signal loss as a result of these error messages is not an indication of signal due to a device malfunction.The root cause of the signal loss is related to user education.As there is no evidence of an nk device malfunction, a capa is not warranted.The following fields are not applicable (na) to this report: b2.D4 lot # & expiration date.D6a & d6b.D7b.F1 - f14.G4 device bla number.G7.H2.H7.H9.The following fields contain no information (ni), as an attempt to obtain information was made, but not provided: a2 - a6 attempt # 1: (b)(6) 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.B6 attempt # 2: (b)(6) 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.B7 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: d10 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.Manufacturer references # 300243785 - 103684 follow up 001.

• 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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11704429
• MDR Text Key: 247286903
• Report Number: 8030229-2021-00243
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ORGS; ORGS