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.

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

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/18/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Date Manufacturer Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse