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

Model Number ORG-9100A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 03/17/2022

Event Type  malfunction  

Event Description

The customer reported that all transmitters on this org are in communication loss (comm loss).There was no patient injury reported.

Manufacturer Narrative

The customer reported that all transmitters on this org are in communication loss (comm loss).Technical support (ts) had the customer reboot the org and the switch as well as the central nurse's station (cns).After the customer did this the org was able to once again monitor all transmitters.There was no patient injury reported.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.Additional model information: concomitant medical device: the following device was used in conjunction with the org: transmitters: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Event Description

The customer reported that all transmitters on this org are in communication loss (comm loss).There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that all transmitters on this org are in communication loss (comm loss).Technical support (ts) had the customer reboot the org and the switch as well as the central nurse's station (cns).After the customer did this the org was able to once again monitor all transmitters.There was no patient injury reported.Investigation summary: root cause is most likely related to customer network environment.No further issues of communication loss have been reported to date.Further action is not warranted.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 03/18/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 03/22/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/24/2022 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 03/18/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 03/22/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/24/2022 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 03/18/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 03/22/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 03/24/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the org: transmitters: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? h10 additional manufacturer narrative.Manufacturer references # (b)(4).

• 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: 14115841
• MDR Text Key: 289467351
• Report Number: 8030229-2022-02743
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• 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
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2014
• 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: CNS.; CNS.; TRANSMITTERS.; TRANSMITTERS.