MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number ZM-520PA

Device Problem Patient Data Problem (3197)

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

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

The biomed reported that the previous day a patient had coded and they noticed data was not recorded.The data had about a 10-11min gap where it was blank.Waveforms were still displaying on the screen but not recorded.No known impact or consequence to the patient.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: attempt #1: 01/22/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs and other relevant history: no reply was received.Attempt #2: 02/01/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs, and other relevant history: no reply was received.Attempt #3: 02/08/2021 emailed customer via microsoft outlook for patient information, relevant tests/labs, and other relevant history: no reply was received.

Event Description

The biomed reported that the previous day a patient had coded and they noticed data was not recorded.The data had about a 10-11min gap where it was blank.Waveforms were still displaying on the screen but not recorded.No known impact or consequence to the patient.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that a patient coded the previous day while being monitored on a telemetry transmitter and found that there was a gap of about 10-11 minutes of recorded data.Waveforms were still displaying on the screen but not recording.No harm or injury was reported.Investigation summary: although we were informed that the patient monitoring was transferred from the transmitter to the bsm, the detailed date which had a data gap was not provided.The log files obtained from the cns were investigated.The logs of "cannot analyze," "signal loss," "electrode off," etc.Were output from around 4:18 pm on (b)(6), 2021, and it was noticed that the pacing mark was mis-detected by reviewing the interrupted waveform at 16:26:20.It seemed that the signal condition had not been good.The log at the time it was transferred to the bsm, which indicated the admitting operation at the bedside monitor (event id:34) was output at 16:37:25 on (b)(6), 2021.This admitting operation was conducted at the bedside monitor, and the data was saved only after the admitting operation above because the patient transfer at the cns was not conducted.The cause of the data gap was found to be caused by the customer not performing a patient transfer at the cns.This resulted in the data not being recorded until the patient was admitted on the bedside monitor.The root cause is related to user workflow and not a result of a device deficiency.There is no evidence of an nk device malfunction that may have contributed to the reported issue.A complaint history review of the customer's account does not reveal trends for similar complaints.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 - b7 d10 attempt #1: (b)(6) 2021 emailed customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt #2: (b)(6) 2021 emailed customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt #3: (b)(6) 2021 emailed customer via microsoft outlook for all information in the ni list above: no reply was received.D10 concomitant medical device: the following devices were used in conjunction with the transmitter: bsm: model #: ni serial #: ni cns: model #: ni serial #: ni additional information: b4 date of this report d10 concomitant medical device g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that a patient coded the previous day while being monitored on a telemetry transmitter and found that there was a gap of about 10-11 minutes of recorded data.Waveforms were still displaying on the screen but not recording.There was no known impact or consequence to the patient.

• Brand Name: ZM-520PA
• 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11334566
• MDR Text Key: 234955098
• Report Number: 8030229-2021-00083
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 4931921115077
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/07/2023
• 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: BSM; CNS