MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that they are having intermittent signal loss issues and artifacts/noise occurring only in one specific department.The biomedical engineer states it is happening in the four (4) east wing and is isolated to just that location.Nihon kohden service engineer went on-site and tightened up three (3) way splitters and aac connections.All antenna's are working as expected.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.(b)(4).

Event Description

The biomedical engineer reported that they are having intermittent signal loss issues and artifacts/noise occurring only in one specific dept.The biomedical engineer states that it is happening in the four (4) east wing and is isolated to just that location.No patient harm was reported.

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 11694237
• MDR Text Key: 247127385
• Report Number: 2080783-2021-00237
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/20/2021

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
• 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: 04/20/2021
• Distributor Facility Aware Date: 03/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1