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.There was no patient injury reported.

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
• MDR Report Key: 12973270
• MDR Text Key: 286565697
• Report Number: 2080783-2021-02109
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2021
• Distributor Facility Aware Date: 11/12/2021
• Device Age: 41 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS; RNS; TRANSMITTERS