MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that their transmitter randomly discharged a patient.No patient harm or injury was reported.This ticket has been created to document the hospital's department logs.The hospital will not be providing any additional information.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 contain no information (ni), as attempts to obtain information were made but not provided: serial number, approximate age of the device.No serial number was provided, so the age of the device is unknown, device manufacturer date.Additional device information: concomitant medical devices: the following device was used in conjunction with the transmitter.Central nurse's station (cns): model #: ni, sn #: 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 biomedical engineer (bme) reported that their transmitter randomly discharged a patient.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6) partners provided log for random discharge on gz nk device.The details of the device with the issue have not been reported at the time of complaint, such reports are addressed under capa: 18-033.Service requested: assistance in troubleshooting.Service performed: customer reported about random discharge on one of the gz devices of nk.However, customer will not provide any further information related to issue or the device.The issue could not be resolved.Root cause of the issue could not be identified as the customer will not corporate with nkts for sharing the information related to reported issue as well as the nk device involved in the issue.Investigation result: root cause of the issue could not be identified as the customer will not corporate with nkts for sharing the information related to reported issue as well as the nk device involved in the issue.Investigation conclusion: root cause of the issue could not be identified as the customer will not corporate with nkts for sharing the information related to reported issue as well as the nk device involved in the issue.Additional device information: d11 & c2 concomitant medical devices: the following device was used in conjunction with the transmitter.Central nurse's station (cns).

Event Description

The biomedical engineer (bme) reported that their transmitter randomly discharged a patient.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 9373389
• MDR Text Key: 194663223
• Report Number: 8030229-2019-00690
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• 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: 01/27/2020

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: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2020
• Distributor Facility Aware Date: 01/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2020
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS; CNS