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

Model Number ZM-530PA

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)

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

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that there were no alarms during a syncopal episode.Multiple events were not captured.There were multiple 3 second pauses not captured or alarming.The central nurse's station (cns) did not alarm and patient was found unresponsive with no pulse.There was no patient death, but the customer noted that it was a near miss.The medtronic (device) was able to capture them.No known impact or consequence to the patient.Concomitant medical products: the following device(s) were being used in conjunction with the telemetry transmitter, but model and serial number information was not provided for the multiple patient receiver and was noted as no information (ni), as attempts to obtain information were made but information was not provided.Central nurse's station: model: cns-6201a, (b)(4).Multiple patient receiver (org): model: ni, sn: ni.

Event Description

The nurse reported that there were no alarms during a syncopal episode.Multiple events were not captured.There were multiple 3 second pauses not captured or alarming.The central nurse's station (cns) did not alarm and patient was found unresponsive with no pulse.There was no patient death, but the customer noted that it was a near miss.No known impact or consequence to the patient.

Manufacturer Narrative

Details of complaint: the nurse reported there were no alarms exhibited at the central nurse's station (cns) for multiple syncopal episodes and the patient was found unresponsive with no pulse.The customer stated that this was a near miss.It was also noted that the medtronic device was able to capture the events.No patient harm or injury was reported.Investigation summary: there was no patient death.In the event description of the adverse event information form, it was indicated that the during a patient event the device did not alarm.The customer indicated that a medtronic device was able to capture the event.The logs were reviewed by nkc.There were many log entrees where it showed "signal loss" and "electrode off." additional information was requested from the customer, however, there was no response from the customer.The log investigation was inconclusive due to the lack of information.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.Due to multiple logs of signal loss and electrode off error messages observed on the logs, possible causes of the issue are poor network environment, bad lead and electrode placement, bad lead and cables.

Event Description

The nurse reported there were no alarms exhibited at the central nurse's station (cns) for multiple syncopal episodes and the patient was found unresponsive with no pulse.No known impact or consequence to the patient.

• 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: 11202505
• MDR Text Key: 244662539
• Report Number: 8030229-2021-00014
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 03/02/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• 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-6201A SN (B)(6); CNS-6201A SN (B)(6); MULTIPLE PATIENT RECEIVER; MULTIPLE PATIENT RECEIVER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Race: Black Or African American