MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER

Model Number GZ-130PA

Device Problem Communication or Transmission Problem (2896)

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

Event Date 04/10/2021

Event Type  malfunction  

Manufacturer Narrative

The customer called for assistance in adding this unit to the central nurse station (cns) to start monitoring.According to the customer, the bed tile they want to add this unit to is greyed out.The customer call back and reported comm loss on several devices (gz transmitters).The support engineer troubleshot the reported comm loss with the customer for a while, but then the customer decided to handle the reported issue with their it service first then if needed, the customer will reach back again.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.

Event Description

The customer reported comm loss on several gz transmitters.

Manufacturer Narrative

Details of complaint: the customer reported they were getting comm loss for several gz transmitters at the central nurse's station (cns).No patient harm was reported.Investigation summary: during the course of troubleshooting, issues relating to the hospital's wireless access points and ip addressing of the gz transmitters were identified.The customer stated they wanted to address the issue with their it team and would call nka should additional assistance be needed.No further correspondence was recorded in the complaint record.As such, a root cause could not be determined.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Root cause is likely related to the hospital's network environment and unlikely to be related to an nk device deficiency.

Event Description

The customer reported they were getting comm loss for several gz transmitters at the central nurse's station (cns).No patient harm was reported.

• Brand Name: GZ-130PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11780769
• MDR Text Key: 280117203
• Report Number: 8030229-2021-00267
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153707
• 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: 09/05/2023

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: GZ-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/05/2023
• 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: CENTRAL NURSE STATION (CNS); CENTRAL NURSE'S STATION (CNS)