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 4 east wing and is isolated to just that location.Nihon kohden service engineer went on-site and tightened up 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 if additional information becomes available.] additional model information: concomitant medical device: the following device was used in conjunction with the unit: antenna power supply: model: a/np-3000.Sn: ni.

Event Description

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

Manufacturer Narrative

Reported issue: 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 4 east wing and is isolated to just that location.Nihon kohden service engineer went on-site and tightened up 3 way splitters and aac connections.All antenna's are working as expected.Investigation summary: nihon kohden investigated the reported event for risk assessment and found the overall risk score score is low.The issue was resolved by tightening the connections on the three-way splitter and aac.The root cause of intermittent comm loss is improper installation.As the issue is not related to a deficiency or non-conformance of an nihon kohden device, a capa is not required.The following fields are not applicable (na) to the mdr report: b2 b6 b7 d4 lot number & expiration d6a - d6b d7b f1 - f14 g4 device bla g5 g7 h2 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 additional model information: d10 concomitant medical device: the following device was used in conjunction with the unit: antenna power supply: model: a/np-3000 sn: (b)(6).

Event Description

Customer reported that they are having intermittent signal loss issues and artifacts/noise occurring only in one specific dept.The biomed states that it is happening in the 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: 11690887
• MDR Text Key: 246450609
• Report Number: 8030229-2021-00237
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1