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

Model Number ORG-9110A

Device Problems Communication or Transmission Problem (2896); Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

Multiple transmitters were used in conjunction with the org , but are not the device that experienced failure.Attempts to obtain the following information were made, but not provided: transmitters: model: ni, s/n: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The customer reported that their multiple patient receiver (org) is intermittently dropping its signal for multiple transmitters that are attached to it.

Manufacturer Narrative

Details of complaint: the customer reported that their multiple patient receiver (org) was intermittently dropping its signal for multiple transmitters that were attached to it while monitoring patients.No patient harm reported.Service requested / performed: troubleshooting.Investigation summary: the device was not returned to nk for evaluation and no logs were provided.Since there was not enough information provided by the customer, no root cause could be determined for this incident.As this issue has an overall risk score of medium, a capa is not required per corrective action and preventive action process, sop07-003.Since the root cause was unable to be determined, no capa is initiated.Without a root cause, the counter measure to prevent recurrence cannot be performed.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with model #: ni.Serial #: ni.Transmitters: model #: ni.Serial #: ni.

Event Description

The customer reported that their multiple patient receiver (org) was intermittently dropping its signal for multiple transmitters that were attached to it.

• 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: 9505692
• MDR Text Key: 194790639
• Report Number: 8030229-2019-00740
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/20/2019,10/07/2021

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2019
• Distributor Facility Aware Date: 11/22/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CNS; MULTIPLE TRANSMITTERS; MULTIPLE TRANSMITTERS