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

Model Number ZM-530PA

Device Problem Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their transmitter ecg waveforms disappeared.The customer also reported that on the screen on the transmitter goes blank while the cns waveform will get very noisy at then eventually disappear.No harm or injury was reported.The customer will be sending this transmitter in for an exchange.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.Additional model information: the cns was used in conjunction with the transmitter, and is not the device that experienced failure.Attempts to obtain the following information were made, but not provided: cns - model: ni, s/n: 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 customer reported that their transmitter ecg waveforms disappeared.

Manufacturer Narrative

Details of complaint: the customer reported that the ecg waveforms on the transmitter disappeared.The screen on the transmitter would go blank, and the waveform at the central nurse's station (cns) would get very noisy, then eventually disappear.There was no error message when this happened.No patient harm or injury was reported.Investigation summary: the biomedical engineer (bme) tested the device with a simulator and was able to observe the issue.The customer indicated that on the cns tile, the waveform would get very noisy and then disappear.A review of the history of the serial number identified no similar events.Based on the available information, a definitive root cause could not be identified.However, it is possible that the device's ecg module was failing.Failure of the module and/or its components can occur due to physical damage.Impacts with surfaces or other objects could damage both the exterior enclosure and internals of the device.Internal damage of the device may cause incomplete sending of data or prohibit the device from connecting to the network, the bsm, or the cns.If physical damage is not observed on the device or its components, a module may fail due to normal wear and tear and is dependent on the age of the device and the frequency of its use.

Event Description

The customer reported that the ecg waveforms on the transmitter disappeared.The screen on the transmitter would go blank, and the waveform at the central nurse's station (cns) would get very noisy, then eventually disappear.

• Brand Name: ZM-530PA
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10071867
• MDR Text Key: 200641785
• Report Number: 8030229-2020-00275
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• 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: 05/19/2020,02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2020
• Distributor Facility Aware Date: 05/04/2020
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2020
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2015
• 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'S STATION (CNS); CENTRAL NURSE'S STATION (CNS)