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

Model Number ZM-530PA

Device Problems Device Alarm System (1012); Improper Alarm (2951)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the transmitter did not alarm for a vtach event.The vtach was visual on the central nurse's station (cns) but no alarm or warning was exhibited.He was provided with some troubleshooting tips that included copying the bedside settings from a known good tile to the one for the failed device, and advised of proper lead placement practices to avoid this issue in the future.He will contact nihon kohden if the issue persists.No patient harm was reported.

Event Description

The biomedical engineer reported that the transmitter did not alarm for a vtach event.The vtach was visual on the central nurse's station (cns) but no alarm or warning was exhibited.

Manufacturer Narrative

Details of complaint: customer reported a series of vtach did not alarm or warn on this device.The vtach was visually on the cns but no alarm or warning was shown.Patient was already discharged.Customer wanted to ensure this device performs problem-free in the future.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: the following troubleshooting steps were performed: 1) walked chris through checking the settings from one tile to another and how to copy bed settings from another tile 2) advised chris he can try copying the bed settings from one tile to the one where this occurred, and perform a simulation for vtach.3) he can also try swapping out this tele with another known good working device and changing the channel, or swap tele devices from one tile to another by changing the channel on both receiver cards on the tiles and simulating.4) let him know it is also important to confirm that lead placement and leads are good, so he can try swapping leads between the devices too.5) offered to escalate to a cas but he did not want to - was more concerned about just replacing the device 6) sent follow-up email with troubleshooting and request for his findings.Customer responded that lead placements were verified and receivers were swapped but there were other problems with their system.It's unclear if this resolved the alarm issue.The other problems customer noted was one patient showing 102-107 for spo2 levels.Customer proceeded to purchase new system.Additional details were not provided.Device was put into service 7/29/2016.Warranty expires 7/28/2021.There are no other tickets created for this device.Device in question zm-530pa sn (b)(4) was not sent in for evaluation.The root cause could not be determined.Further investigation is not possible at this time.

Event Description

The biomedical engineer reported that the transmitter did not alarm for a vtach event.The vtach was visual on the central nurse's station (cns) but no alarm or warning was exhibited.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018 customer reported a series of vtach did not alarm or warn on the cns.The vtach was visible on the cns but no alarm or warning was shown.Patient was already discharged.Customer wanted to ensure this device performs problem-free in the future.The model and serial number for the cns is not available.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: the following troubleshooting steps were performed: "1) walked chris through checking the settings from one tile to another and how to copy bed settings from another tile 2) advised chris he can try copying the bed settings from one tile to the one where this occurred, and perform a simulation for vtach.3) he can also try swapping out this tele with another known good working device and changing the channel, or swap tele devices from one tile to another by changing the channel on both receiver cards on the tiles and simulating.4) let him know it is also important to confirm that lead placement and leads are good, so he can try swapping leads between the devices too.5) offered to escalate to a cas but he did not want to - was more concerned about just replacing the device 6) sent follow-up email with troubleshooting and request for his findings" customer responded that lead placements were verified and receivers were swapped.It's unclear if this resolved the alarm issue.Customer proceeded to purchase new system.Additional details were not provided.Device was put into service 7/29/2016.Warranty expires 7/28/2021.There are no other tickets created for this device.Customer has one other ticket created relating vtach alarm: 53494.The root cause of this incident was determined to be user error.Device in question zm-530pa sn (b)(6) was not sent in for evaluation.The root cause could not be determined.Further investigation is not possible at this time.Update 10/4/2019: without knowing the alarm settings alarm settings at the time of the event, it is not possible to determine the root cause of why cns did not alarm for vtach.Service history for this customer shows three other alarm incidents: 53494 - reported 3/9/2019.Customer technician was not aware of patient using a pacemaker, thus appropriate adjustments were not accounted for, causing the missed vtach alarms.42150 - reported on 10/18/2018.Customer needed information on how to pull alarm data.Not related to missed alarms.30570 - reported on 6/1/2018.Customer needed assistance on how to adjust alarm settings.Not related to missed alarm.Based on the above data, the reported issue has not re-occurred - it is an isolated incident.Correction: b2.Outcomes attributed to adverse event.Required intervention to prevent permanent impairment/damage (devices) was incorrectly selected.De-selected in smdr follow up 002.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 7311476
• MDR Text Key: 101473539
• Report Number: 8030229-2018-00058
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• 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,Followup
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2019
• Distributor Facility Aware Date: 10/04/2019
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2019
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: CNS: NO MODEL/SERIAL
• Patient Outcome(s): Required Intervention