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 Known Impact Or Consequence To Patient (2692)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their central nurse's station (cns) is showing communication loss for a single multiple patient receiver (org).Nk ts logged into the system and found that this org does not show in the org settings or the cns host table.No patient harm or injury was reported.The customer will be sending the failed unit in for a repair and further evaluation.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 device information: the following devices were used in conjunction with the org, but did not experience failure: cns - model: pu-621ra: s/n: (b)(4).Approximate age of the device: 54 months.Device manufacturer date: 05/29/2019 unique identifier (udi) #: (b)(4).Attempts to obtain the following information were made, but not provided: variety of transmitters - model #: ni, s/n #: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The customer reported that their central nurse's station (cns) is showing communication loss for a single multiple patient receiver (org).

Event Description

The customer reported that their central nurse's station (cns) is showing communication loss for a single multiple patient receiver (org).

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6)health ctr reported one org (org-9100a sn: (b)(6)) in communication loss.The communication loss was affecting 8 rooms (rooms 259-267), and there was a total of two patients being monitored at the time.Service requested / performed: repair.Investigation summary: approximate age of the org at the time of reported issue was 4 years.The unit has no history of nka servicing or repair.Customer's maintenance history for this unit is not available.No pattern of org caused communication loss issues was found for the unit sn: (b)(6) or the user facility.The probable root cause is determined to be normal deterioration of the org cpu board #ur-3981.Per nka chief medical officer, there is a remote probability of adverse event requiring medical intervention.The severity of the issue is considered minor.The probability for communication loss due to failure of part #ur-3981 is determined to be rare (less than 1% of the time).The overall risk is low.Additional device information: d11 & c2: the following devices were used in conjunction with the org, but did not experience failure: cns - model: pu-621ra s/n: (b)(6).Approximate age of the device: 54 months.Device manufacturer date: 05/29/2019.Unique identifier (udi) #: (b)(4).Attempts to obtain the following information were made, but not provided: variety of transmitters - model #: ni.S/n #: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni.Unique identifier (udi) #: ni.

• Brand Name: ORG-9100A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 9441074
• MDR Text Key: 200824577
• Report Number: 8030229-2019-00712
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2020
• Distributor Facility Aware Date: 02/13/2020
• Device Age: 56 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS; CNS; VARIETY OF TRANSMITTERS; VARIETY OF TRANSMITTERS