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 Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (org) failed and the transmitters being monitored experienced intermittent signal loss.The intermittent signal loss problem started happening after completing a renovation on that floor and four additional rooms for monitoring were added.This is also the only floor that currently use both uhf and l-band frequencies.No patient harm was reported.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 model information: the following devices were used in conjunction with the org.Central nurse's station, model: cns-6201a, s/n: (b)(4).Transmitter, model: zm-530pa, s/n: (b)(4).Transmitter, model: zm-530pa, s/n: (b)(4).

Event Description

The biomedical engineer reported that the multiple patient receiver (org) failed and the transmitters being monitored experienced intermittent signal loss.No patient harm was reported.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019, customer at st.Francis health system reported the multiple patient receiver (org-9100a sn: (b)(6) was having intermittent signal loss.The issue had been ongoing for the past three to four months.Investigation conclusion: the pattern of reported signal loss at the customer facility may point to issues with the infrastructure, interference, or workflow.These factors are not under nka control and must be managed by the facility to ensure proper environment for the unit to work as expected.As the customer did not wish to return the unit for nka evaluation, information is limited and the root cause/risk assessment cannot be performed.There is insufficient information to suspect a non-conformance of the org.No further issues have been reported against sn: (b)(6).Additional device information: d11 & c2: the following devices were used in conjunction with the org.Central nurse's station: model: cns-6201a.S/n: (b)(6).Transmitter: model: zm-530pa.S/n: (b)(6).Transmitter: model: zm-530pa.S/n: (b)(6).

Event Description

The biomedical engineer reported that the multiple patient receiver (org) failed and the transmitters being monitored experienced intermittent signal loss.No patient harm was reported.

• 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: 9210977
• MDR Text Key: 163121869
• Report Number: 8030229-2019-00578
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2020
• Distributor Facility Aware Date: 03/24/2020
• Device Age: 85 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2020
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PU-621RA SN (B)(6); PU-621RA SN (B)(6); ZM-530PA SN (B)(6); ZM-530PA SN (B)(6); ZM-530PA SN (B)(6); ZM-530PA SN (B)(6)