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

Model Number ZM-531PA

Device Problems Device Alarm System (1012); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter did not alarm for atrial fibrillation (afib).Nk technical support explained that if the zm transmitter does not alarm.It should send the alarm information to the central nurse' station (cns), which should alarm.The bme was not sure if that happened.The bme is unsure how the nurses determined that the transmitter should have, but did not, alarm and he stated they do not feel comfortable using that transmitter anymore.The patient was no longer there and discharged, so the event logs could not be collected.They are sending the transmitter in for evaluation.No patient harm 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 when additional information becomes available.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter did not alarm for atrial fibrillation (afib).Nk technical support explained that if the zm transmitter does not alarm.It should send the alarm information to the central nurse' station (cns), which should alarm.The bme was not sure if that happened.The bme is unsure how the nurses determined that the transmitter should have, but did not, alarm and he stated they do not feel comfortable using that transmitter anymore.The patient was no longer there and discharged, so the event logs could not be collected.They are sending the transmitter in for evaluation.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter did not alarm for atrial fibrillation (afib).Nk technical support explained that if the zm transmitter does not alarm.It should send the alarm information to the central nurse' station (cns), which should alarm.The bme was not sure if that happened.The bme is unsure how the nurses determined that the transmitter should have, but did not, alarm and he stated they do not feel comfortable using that transmitter anymore.The patient was no longer there and discharged, so the event logs could not be collected.They are sending the transmitter in for evaluation.No patient harm was reported.

Manufacturer Narrative

Details of complaint: on 9/3/2019 customer biomed relayed the message for the nursing staff that zm transmitter did not detect an atrial fibrillation patient event.The transmitter did not show it.The biomed was not present during the event so he has limited information.Additional information regarding transmitter settings, operating mode, receiving monitor's settings were not available.Customer asked to send device to nka for evaluation and/or repairs as necessary.Service requested: evaluation.Service performed: evaluation.Investigation result: the intended use of zm transmitter device is to wirelessly transmit the ecg and respiration data from the patient to the central monitor for continuous monitoring.The front lcd displays ecg, numeric values of monitoring parameters, messages and battery condition.Operator's manual revision e states that "alarms suspended" is displayed on the transmitter, alarms on the receiving monitor (cns device) are suspended.The manual also warned user that when only spo2 parameter is being monitored, detection of arrhythmia and asystole is not available.As such the arrhythmia alarms are not available.Ecg monitoring should be selected.The settings on the transmitter should match that of the monitoring device (cns).As the function of the transmitter is to send data to a receiving monitor, it does not display alarms other than "low battery" warning.Per operator's manual, alarms must be managed on the receiving monitor.Nka repair center evaluated the device on 10/10/2019.The reported issue could not be duplicated.Separately, the evaluation noted device appeared to have fluid intrusion at one time.Additionally, device has a hairline crack on the front and rear case assembly.Due to the observed damage and fluid intrusion, the following parts were replaced as a precautionary measure: -cd-322p-01 center case -6142902694 - rear battery assembly -6142902553 - front case assembly -110168 - o ring -6114918572a case sealant -6123906838 main panel -6124906985 label device was put into service on 2/15/2017.Service history for this device shows this is an isolated incident.Service history for this user facility shows no related events.Due to the limited information provided by customer, the root cause of the issue could not be determined.Device was evaluated and tested at nka repair center.There was no performance issues found.Investigation conclusion: due to the limited information provided by customer, the root cause of the issue could not be determined.Device was evaluated and tested at nka repair center.There was no performance issues found.The following field contains no information (ni), as attempts to obtain information were made, but not provided: d11 & c2: concomitant medical device information.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 9121041
• MDR Text Key: 199135602
• Report Number: 8030229-2019-00491
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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
• Date Returned to Manufacturer: 09/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2019
• Distributor Facility Aware Date: 12/09/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1