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

Model Number GZ-130PA

Device Problem Patient Data Problem (3197)

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

Event Date 04/04/2024

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the ecg waves are intermittently dropping from the gz transmitter and at the remote nurse's station (rns) so the biomed swapped it out with another gz transmitter on the patient, no patient harm was reported.Biomed reported they ran the device on a simulator and it still continued to drop ecg waves.No physical damage to the unit reported.Biomed requested a warranty exchange unit and will return this gz transmitter to nihon kohden.

Manufacturer Narrative

The biomedical engineer (bme) reported that the ecg waves are intermittently dropping from the gz transmitter and at the remote nurse's station (rns) so the biomed swapped it out with another gz transmitter on the patient, no patient harm was reported.Biomed reported they ran the device on a simulator and it still continued to drop ecg waves.No physical damage to the unit reported.Biomed requested a warranty exchange unit and will return this gz transmitter to nihon kohden.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.

• 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; 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: 19192831
• MDR Text Key: 341493042
• Report Number: 8030229-2024-04235
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/26/2024

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: 04/04/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2019
• 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: RNS