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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this org has an intermittent signal loss issue.According to the customer, the tele units that the org monitors will all go into signal loss for a few minutes before returning to a connected status.This is happening 2-3 times a day.The customer is sending in the unit to be exchanged.There was no patient injury 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.Attempt # 1: on (b)(6)2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have patient info.All items are unknown.

Event Description

The customer reported that this org has an intermittent signal loss issue.There was no patient injury reported.

Event Description

The customer reported that this org has an intermittent signal loss issue.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this org has an intermittent signal loss issue.According to the customer, the tele units that the org monitors will all go into signal loss for a few minutes before returning to a connected status.This is happening 2-3 times a day.The customer is sending in the unit to be exchanged.There was no patient injury reported.Investigation summary: the reported device was not returned for evaluation, root cause cannot be determined.However, it should not be ruled out that environmental factors specific to the reported device are potential contributors to the signal loss.The cpu board unit was not replaced since its initial install on approximately 02/2014 and could be a potential cause due to its degradation from wear and tear or aging.The following fields are not applicable (na) to this report: the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6.Attempt # 1: 06/28/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have patient info.All items are unknown.B6: attempt # 1: 06/28/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have patient info.All items are unknown.B7: attempt # 1: 06/28/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have patient info.All items are unknown.D10: attempt # 1: 06/28/2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have patient info.All items are unknown.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow up, what type? manufacturer references # (b)(4).Follow up 001.

• 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
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 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: 15075146
• MDR Text Key: 304417126
• Report Number: 8030229-2022-02973
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• 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: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• 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
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1