MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problems Application Program Problem (2880); Communication or Transmission Problem (2896)

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

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

According to the customer, 5 teles will not let them admit and 1 is in comm loss.Per the customer, there were 3 teles that would not admit and one that was in comm loss at the cns.The rns showed 2 teles that would not admit.Technical support (ts) spoke with biomed, a charge nurse and a monitor tech and it all came down to 4 teles not being able to admit.The issue was resolved by powering one org that had been turned off as the power cable was disconnected.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.Concomitant medical device: the following device was used in conjunction with the org: transmitters: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.

Event Description

The customer reported the central nurse's station (cns) and the remote nurse's station (rns) experienced communication loss (comm loss) and/or admit issues.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported the central nurse's station (cns) and the remote nurse's station (rns) experienced communication loss (comm loss) and/or admit issues.According to the customer, 5 teles will not let them admit and 1 is in comm loss.Per the customer, there were 3 teles that would not admit and one that was in comm loss at the cns.The rns showed 2 teles that would not admit.Technical support (ts) spoke with biomed, a charge nurse and a monitor tech and it all came down to 4 teles not being able to admit.The issue was resolved by powering one org that had been turned off as the power cable was disconnected.There was no patient injury reported.Investigation summary: nk tech support advised the customer to check the org and found that the org was powered off due the power cable being disconnected.Powering on the org resolved the issue of communication loss.The root cause of communication loss due to unconnected cable is use error.As there is no evidence of an nk device malfunction, a capa is not warranted.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the org:, cns:, model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.D10 concomitant medical device: the following device was used in conjunction with the org:, rns:, model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.D10 concomitant medical device: the following device was used in conjunction with the org:, transmitters:, model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.Manufacturer references # 300274996 - 124977 follow up 001.

Event Description

The customer reported the central nurse's station (cns) and the remote nurse's station (rns) experienced communication loss (comm loss) and/or admit issues.There was no patient injury reported.

• Brand Name: ORG-9110A
• 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: 12973264
• MDR Text Key: 284117053
• Report Number: 8030229-2021-02109
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

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-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2018
• 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; RNS; RNS; TRANSMITTERS; TRANSMITTERS