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

Model Number ORG-9110A

Device Problems No Display/Image (1183); Data Problem (3196)

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

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this transmitter is not showing the heart rate (hr) numeric value on the central nurse's station (cns).The technical service area manager (tsam) initialized the org to resolve the issue.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to get the information requested.B6 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to get the information requested.B7 attempt # 1: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to get the information requested.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the model #: 681ra.Returned to nihon kohden: no.Zm transmitter: model #: 531pa.Returned to nihon kohden: no.The following fields are not available (n/a) to this report: h4 device manufacturer date.

Event Description

The customer reported that this transmitter is not showing the heart rate (hr) numeric value on the central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this transmitter is not showing the heart rate (hr) numeric value on the central nurse's station (cns).The technical service area manager (tsam) initialized the org to resolve the issue.There was no patient injury reported.Investigation summary: the investigation confirmed that the phenomenon could be reproduced when on the hiq-view function of the bedside monitor g5/g7.When switching the 6-electrode leads and the 3-electrode leads for the ecg of the zm transmitter, the g5/g7 operated to set the lead i to the chest leads (c1, c2).The correct behavior is to set one of the v1 to v6 leads for the chest leads (c1, c2).Cause: software of the g5/g7 countermeasure: software of the g5/g7 (ver.02-27) release schedule august, 2023 although the customer reported that the hiq-view function was not used when the phenomenon of the 1st issue happened, it could not be identified from the log information whether the hiq-view function was used because the log information didn't include the history when the phenomenon happened.Manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported that this transmitter is not showing the heart rate (hr) numeric value on the central nurse's station (cns).There was no patient injury 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
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16778066
• MDR Text Key: 313669228
• Report Number: 8030229-2023-03478
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CNS; CNS; ZM TRANSMITTER; ZM TRANSMITTER