MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9100A

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) is showing communication loss for monitored device(s) for about 2-10 seconds at a time.No patient(s) were harmed.Attempt # 1: on 08/05/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: on 08/18/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: on 08/20/2021 emailed the customer via microsoft outlook for patient information: reply was received but no patient demographics were provided.Additional device information: concomitant medical device: the following device(s) were in use in conjunction with the org: central nurse's station: model #: pu-681ra; serial #: (b)(4); device manufacturer data: 07/24/2018; unique identifier (udi) #: (b)(4).Transmitter: model #: zm-520pa; serial #: ni; device manufacturer data: ni; unique identifier (udi) #:(b)(4).

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) is showing communication loss for monitored device(s) for about 2-10 seconds at a time.No patient(s) were harmed.

• Brand Name: ORG-9100A
• 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: 12372327
• MDR Text Key: 268364321
• Report Number: 2080783-2021-01667
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2021
• Distributor Facility Aware Date: 07/29/2021
• Device Age: 3 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PU-681RA; ZM-520PA