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

Model Number ZM-530PA

Device Problems Communication or Transmission Problem (2896); Output Problem (3005)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  Death  

Event Description

The customer reported that a patient expired while being monitoring on a transmitter at the time the device was experiencing signal loss.The signal loss occurred for about 10 minutes.The device showed only artifact when coming out of signal loss for a few seconds 2 times during the reported 10-minute signal loss duration.When the device came out of signal loss, the staff was alerted to a vfib alarm and when checking on the patient, it was discovered that the patient had passed away.

Manufacturer Narrative

The customer reported that a patient expired while being monitoring on a transmitter at the time the device was experiencing signal loss.The signal loss occurred for about 10 minutes.The device showed only artifact when coming out of signal loss for a few seconds 2 times during the reported 10-minute signal loss duration.When the device came out of signal loss, the staff was alerted to a vfib alarm and when checking on the patient, it was discovered that the patient had passed away.Log files were requested from all involved devices and will be reviewed when received.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 device information: concomitant medical device: the following devices were used in conjunction with the transmitter: central nurse's station (cns): model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni.Multiple patient receiver (org): model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni.Attempt # 1: 10/05/2022 emailed the customer for patient and concomitant device information: no detailed information was received.Attempt # 2: 10/07/2022 emailed the customer for patient and concomitant device information: no detailed information was received.Attempt # 3: 10/11/2022 emailed the customer for patient and concomitant device information: no detailed information was received.

Manufacturer Narrative

Details of complaint: the customer reported that a patient expired while being monitoring on a transmitter at the time the device was experiencing signal loss at the central nurse's station (cns).The signal loss occurred for about 10 minutes.The device showed only artifact when coming out of signal loss for a few seconds 2 times during the reported 10-minute signal loss duration.When the device came out of signal loss, the staff was alerted to a vfib alarm and when checking on the patient, it was discovered that the patient had passed away.Investigation summary: signal loss occurred for about 10 minutes, 2:44am to 2:54am ((b)(6) 2022) during which time a patient death occurred.Nihon kohden technical support (nk ts) requested cns logs from the biomedical engineer (bme).An nk investigation was initiated.Nk ts spoke with the bme and facility directors and an onsite check of the system was requested.The onsite technician performed an assessment of the monitoring system and investigation results are as follows: root cause analysis: no outside interference was present in the system observed.Battery and electrodes were replaced on a couple of patients and the signal loss was greatly reduced or eliminated.The tele box in room 236 serial number (b)(6) did not improve after the above actions were taken.The tele box was replaced with a newer box and the signal loss was eliminated.A comparison test was conducted between the old tele box and the new tele box with 4 different tests.Tests were performed with different antennas and at different distances.Results of the test concluded that the new tele box did not experience any signal loss, while the old tele box experienced some signal loss.The onsite technician made the following recommendations: replace any tele boxes that exhibit a weak signal strength or have consistent signal loss.Electrode replacement should be completed daily or as necessary.When signal loss occurs, consider changing the batteries and/or electrodes.The information available reasonably suggests that the signal loss occurred due to an old tele box, long past its warranty period and/or weak batteries.Review of serial number history finds no previous occurrence signal loss.Additional information: b4 date of this report d8 was this device serviced by a third party? d9 device available for evaluation? d10 concomitant medical device g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The customer reported that a patient expired while being monitoring on a transmitter at the time the device was experiencing signal loss.The signal loss occurred for about 10 minutes.The device showed only artifact when coming out of signal loss for a few seconds 2 times during the reported 10-minute signal loss duration.When the device came out of signal loss, the staff was alerted to a vfib alarm and when checking on the patient, it was discovered that the patient had passed away.

Event Description

The customer reported that a patient expired while being monitoring on a transmitter at the time the device was experiencing signal loss.The signal loss occurred for about 10 minutes.The device showed only artifact when coming out of signal loss for a few seconds 2 times during the reported 10-minute signal loss duration.When the device came out of signal loss, the staff was alerted to a v-fib alarm and when checking on the patient, it was discovered that the patient had passed away.

Manufacturer Narrative

Details of complaint: the customer reported that a patient expired while being monitoring on a transmitter at the time the device was experiencing signal loss at the central nurse's station (cns).The signal loss occurred for about 10 minutes.The device showed only artifact when coming out of signal loss for a few seconds 2 times during the reported 10-minute signal loss duration.When the device came out of signal loss, the staff was alerted to a vfib alarm and when checking on the patient, it was discovered that the patient had passed away.Investigation summary: signal loss occurred for about 10 minutes, 2:44am to 2:54am (10/05/2022) during which time a patient death occurred.Nihon kohden technical support (nk ts) requested cns logs from the biomedical engineer (bme).The device event logs were sent in for analysis and an nk investigation was initiated.Signal loss was discovered and was found to be caused by a malfunctioning transmitter.As no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.The transmitter was observed to be outputting a weak signal which may be a result of malfunctioning hardware.Hardware failure could come as a result of physical damage, fluid damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Fluid intrusion would result in electrical damage to internal components as well as possible corrosion.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.The device was installed in 01/2014 with no history of servicing.The root cause is likely related to wear and tear.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 b6 - b7 d10 attempt # 1: 10/05/2022 emailed the customer via microsoft outlook for additional device and patient information: no reply was received.Attempt # 2: 10/06/2022 emailed the customer via microsoft outlook for additional device and patient information: no reply was received.Attempt # 3: 10/07/2022 emailed the customer via microsoft outlook for additional device and patient information: the customer replied that the requested information cannot be provided.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the transmiiter: central nurse's station (cns): model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: na multiple patient receiver (org): model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: na.

• 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 ; 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: 15724036
• MDR Text Key: 303021044
• Report Number: 8030229-2022-03181
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2024

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: 10/05/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 01/25/2023; 01/03/2024
• Supplement Dates FDA Received: 02/16/2023; 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2013
• 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; CNS; ORG; ORG; ORG
• Patient Outcome(s): Death
• Patient Sex: Male