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 Consequences Or Impact To Patient (2199)

Event Date 06/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org is experiencing intermittent signal loss in a whole department.No patient harm or injury were reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.The following devices were being used in conjunction with the org.Concomitant medical product: central nurses station (cns).Model: pu-681ra.Serial number (b)(4).

Event Description

The customer reported that the org is experiencing intermittent signal loss in a whole department.No patient harm or injury were reported.

Event Description

The customer reported that the org is experiencing intermittent signal loss in a whole department.No patient harm or injury were reported.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, nursing manager (b)(6) at (b)(6) hospital reported that the signal in the department (east 4) was unreliable due to intermittent signal loss.East 4 was a department that sends all its information to abbot northwestern.Service requested: customer requested onsite support.Service performed: customer was informed nka has been working on the signal loss at abbott.There was no concrete solution.Nka technical support (ts) worked with bme richard wild to test the signal loss.Bme was advised to walk around the department slowly and observe full disclosure after.Bme reported no loss, only small spikes of artifact (normal) and he accidentally disconnected a lead.Multiple attempts were made to contact the customer, receiving no response.Investigation summary: due to the lack of information provided along with lack of customer response, information is limited, and the root cause could not be confirmed.Troubleshooting with the bme at the facility was unable to reproduce the reported signal loss.No pattern of department wide signal loss has been reported at (b)(6) hospital.Risk assessment conducted per sop07-018 determined the issue poses medium risk.Controls taken to reduce the risk of harm caused by transmitter signal loss includes advising the operator of the limitations of the nk monitoring system as well as fail safe design which alerts the operator of signal loss.

• Brand Name: ORG-9110A
• 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: 8719270
• MDR Text Key: 149502135
• Report Number: 8030229-2019-00229
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

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-9110A
• Device Catalogue Number: ORG-9110A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2020
• Distributor Facility Aware Date: 04/30/2020
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2020
• Initial Date Manufacturer Received: 06/01/2019
• Initial Date FDA Received: 06/20/2019
• Supplement Dates Manufacturer Received: 04/30/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: CENTRAL NURSES STATION (CNS); CENTRAL NURSES STATION (CNS)TRANSMITTERS