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

Model Number ZM-530PA

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

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

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their transmitter missed an ecg alarm.The customer also reported that the ecg alarm is set to 130, but they saw a reading of a 150, which was the reading that didn't alarm.No harm or injury was reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that their transmitter missed an ecg alarm.The customer also reported that the ecg alarm is set to 130, but they saw a reading of a 150, which was the reading that didn't alarm.

Event Description

The customer reported that the transmitter missed an ecg alarm.The ecg alarm was set to 130, but they saw a reading of a 150, which was the reading that did not alarm.

Manufacturer Narrative

Details of complaint: the customer reported that the transmitter missed an ecg alarm.The ecg alarm was set to 130, but they saw a reading of a 150, which was the reading that did not alarm.No patient harm or injury was reported.Investigation summary: the customer indicated that they were having dropouts on the zm transmitters, but they were not seeing signal loss error messages.The customer mentioned other issues regarding a ghost signal (ticket 101647) and a random chime sound on the cns (ticket 104008).The logs for this issue were collected and were investigated on ticket 97226.The log review was inconclusive, but there were many logs observed with "signal loss" and "electrode off" errors.This suggests there may have been connection issues between the zm device and the cns.A review of the serial number identified no similar events.There is not enough information to identify the root cause of the issue.Due to multiple logs of "signal loss" and "electrode off" error messages observed on the logs, a possible cause of the issue is poor network environment.If a patient event occurred during a signal drop out, the event may not be properly captured on the cns and may not alarm.Without knowing the root cause, countermeasures to prevent recurrence of the issue could not be performed.On a note on 1/27/2021 on a network related ticket (97229), the software of the orgs and the receiver cards (zr-920p) of the facility were updated to improve signal reception, which may alleviate the network connections experienced by the customer with zm devices and cnss.

• 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: 11227102
• MDR Text Key: 240380012
• Report Number: 8030229-2021-00029
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2017
• 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: CENTRAL NURSE'S STATION (CNS); CENTRAL NURSE'S STATION (CNS)