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 11/01/2019

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.

Event Description

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

Manufacturer Narrative

Details of the complaint.Customer at (b)(6) reported the following issue: 11/1 @2130 gz 20 random discharge.Investigation summary: there was a documented incident regarding a random discharge of the gz transmitter.It is unknown if this was caused by user or by the system.The details surrounding the incident were not provided and information on the extent of any troubleshooting is unknown.Further investigation of the issue is limited as the device information were not provided nor were logs retrieved for evaluation.The customer was not willing to provide further information.This was confirmed under notification (b)(4) (ticket (b)(4)).As information needed to conduct an investigation is not available, no root cause analysis or risk assessment could be performed.The following fields contain no information (ni), as attempts to obtain information were made but not provided: d4 serial number; f9 approximate age of the device.No serial number was provided, so the age of the device is unknown; h4 device manufacturer date.Additional device information: d11 & c2 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.

• 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: 9373399
• MDR Text Key: 196097803
• Report Number: 8030229-2019-00689
• 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: 02/12/2020

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: 02/12/2020
• Distributor Facility Aware Date: 02/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2020
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CNS; CNS