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

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this facility is having tele communication dropping out for 30 seconds.The teles go into communication loss (comm loss) for all the beds then they go into bed not found and then come out of comm loss.Technical support (ts) asked the customer to check the org closet to see if the org's can be rebooted and check for error lights or any error lights on the switches.The customer stated he didn't see any error lights, but turned off the orgs for 30 seconds and rebooted the central nurse's station (cns); however, this did not resolve the issue.The customer will send in the unit to be repaired.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.D10 concomitant medical device: the following device was used in conjunction with the org: cns: model #: ni.Serial #: ni.Device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: ni.D10 concomitant medical device: the following device was used in conjunction with the org: zm transmitters: model #: ni serial #: ni device manufacturer date: ni unique identifier (udi) #: ni returned to nihon kohden: ni.

Event Description

The customer reported that this facility is having tele communication dropping out for 30 seconds.There was no patient injuryreported.

• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18527297
• MDR Text Key: 333478239
• Report Number: 8030229-2024-04017
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2015
• 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; ZM TRANSMITTERS