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

Model Number GZ-130PA

Device Problems Communication or Transmission Problem (2896); Data Problem (3196); Patient Data Problem (3197)

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

Event Date 04/04/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they did a patient transfer between a transmitter and a bedside monitor (bsm) and the data was successfully transferred initially, but when they attempted to transfer this data back to the original device, the data was incorrect.The data that was transferred belonged to a different patient that was discharged two weeks prior.No harm or injury occurred.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.The following fields are not applicable (na) to this report: additional device information: concomitant medical device: the following device was used in conjunction with the gz transmitter: bsm: model #: bsm-1700, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni.

Event Description

The customer reported that they did a patient transfer between a transmitter and a bedside monitor (bsm) and the data was successfully transferred initially, but when they attempted to transfer this data back to the original device, the data was incorrect.The data that was transferred belonged to a different patient that was discharged two weeks prior.No harm or injury occurred.

Manufacturer Narrative

Details of complaint: the customer reported that when performing a patient transfer from a gz transmitter to a bedside monitor (bsm), the data was initially transferred successfully, but when attempting to transfer this data back to the gz transmitter, the data was incorrect at the central nurse's station (cns).The transferred data belonged to a different patient that was discharged two weeks prior.No patient harm was reported.Investigation summary: the customer was able to resolve the issue by finding the correct patient, but they could not detail how this was done.The device logs were sent in for nkc evaluation.Clinicians losing visibility of the intended patient vital signs on the cns could potentially lead to delay in treatment and contribute to a patient injury.Proper response to the event is contingent on the clinician's ability to recognize that the incorrect patient was being monitored.The cns is able to display specific bed names which can identify which patient is being monitored.Based on an nkc investigation, the customer selected the incorrect patient, which resulted in then seeing the incorrect patient on the cns.The root cause for this issue is use error.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the gz transmitter: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Bsm: model #: bsm-1700.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.

Event Description

The customer reported that they did a patient transfer between a transmitter and a bedside monitor (bsm) and the data was successfully transferred initially, but when they attempted to transfer this data back to the original device, the data was incorrect.The data that was transferred belonged to a different patient that was discharged two weeks prior.No harm or injury occurred.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14289368
• MDR Text Key: 295443739
• Report Number: 8030229-2022-02830
• 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,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• 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
• Date Manufacturer Received: 06/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2020
• 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: BEDSIDE MONITOR (BSM); BEDSIDE MONITOR (BSM); CENTRAL NURSE'S STATION (CNS)