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).

• 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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, 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: 9441074
• MDR Text Key: 200824577
• Report Number: 8030229-2019-00712
• Device Sequence Number: 1
• Product Code: DRG
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Is the Reporter a Health Professional?: Yes
• 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
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse