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 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the org displayed communication loss (comm loss) at the central nurse's station (cns).The customer located the org in the closet and rebooted.Once the unit was rebooted, the comm loss went away.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.Additional model information: concomitant medical device: the following device was used in conjunction with the org: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Event Description

The customer reported that the org displayed communication loss (comm loss) at the central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the org displayed communication loss (comm loss) at the central nurse's station (cns).The customer located the org in the closet and rebooted.Once the unit was rebooted, the comm loss went away.There was no patient injury reported.Investigaton summary: as the device was not returned for evaluation, root cause cannot be determined.As the issue was resolved after the org was rebooted, it is unlikely that the issue is related to a deficiency in hardware.As the root cause is unlikely to be related to a device malfunction, the issue was resolved by rebooting, and the incident likely being an isolated incident based on complaint history reviews of the customer account and device serial number.The following fields are not applicable (na) to this report: b2 d4 lot # & expiration date d6a & d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: (b)(6)/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2022 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the org: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: ni additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h10 additional manufacturer narrative manufacturer references # 300293481 - 140181 follow up 001.

Event Description

The customer reported that the org displayed communication loss (comm loss) at 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 ; 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: 14581515
• MDR Text Key: 294058830
• Report Number: 8030229-2022-02878
• 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: 08/17/2022

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
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2014
• 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