MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

Device Problem Loss of Data (2903)

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

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the unit drops ecg waveforms.According to the customer, the unit will loose the ecg at the central nurse's station (cns); however, the customer did not have anymore details.There was no patient injury reported.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.

Event Description

The customer reported that the unit drops ecg waveforms.According to the customer, the unit will loose the ecg at the central nurse's station (cns); however, the customer did not have anymore details.There was no patient injury reported.

Event Description

The customer reported that the unit drops ecg waveforms.According to the customer, the unit will loose the ecg at the central nurse's station (cns); however, the customer did not have anymore details.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the unit drops ecg waveforms.According to the customer, the unit will loose the ecg at the central nurse's station (cns); however, the customer did not have anymore details.There was no patient injury reported.Investigation summary: nk repair center evaluated the complaint unit and was not able duplicate the reported issue.This suggests that the telemetry device is not defective.Based on the available information, a definitive root cause could not be identified.As there were no defects observed on the telemetry device.The reported issue could not be duplicated and could not be confirmed by nk repair center, and a definitive root cause could not be identified.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 09/10/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 09/10/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 1: 09/10/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: concomitant medical device: the following device was used in conjunction with the transmitter: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: ni manufacturer references # (b)(4) follow up 001.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• 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: 12457487
• MDR Text Key: 280764338
• Report Number: 8030229-2021-01738
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/27/2022

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-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2017
• 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: CNS; CNS