MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number ZM-531PA

Device Problems Electrical /Electronic Property Problem (1198); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operational Issue (2914)

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

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

The biomedical engineer reported that a telemetry patient claims he was shocked by the leads.The bme states he does not have the leads and he has no idea where the leads are.The nursing staff also does not know where the leads are.The bme reports that there is no physical damage or fluid intrusion.He states that the batteries were new in the device and the leads were a few months old.He tried the device on a simulator in his shop and there does not appear to be an issue.The patient has no injury and has been discharged.The unit is being exchanged under warranty and will be sent in for investigation.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 reported that a telemetry patient claims he was shocked by the leads.

Manufacturer Narrative

(b)(6) reported on 2/22/2018 that one of their tele patients on their zm-521pa s/n (b)(4) claimed they were shocked by the leads.The customer does not have the leads and the nursing staff is unsure where the leads are.According to the customer the batteries were new in the device and the leads were a few months old.The device was tested on a simulator at the customer's facility and there did not appear to be any issues.The patient had no injury.Service requested: exchange.Service performed: exchange.The customer was sent an exchange unit to resolve the issue.The customer's defective unit was received.Per qa evaluation, the transmitter itself was found to be in good working order when new batteries were inserted.The device is low voltage and there were no signs of fluid intrusion, therefore it is unlikely the device contributed to shock.The leads required for investigation were not returned.Investigation result(s): the root cause of the issue could not be identified due to being unable to duplicate the reported issue and being unable to obtain leads for investigation.When the device was returned to nka, it was tested with new batteries and the device was found to be working without issue.The device serial number history shows that there have been no previously reported issues nor servicing for "patient shocked by leads." review of the device history record (dhr) shows that the unit has no history of ncmr, capa, or other suspected defects.Trending analysis for the reported issue yielded no similar results.This indicates that the issue of leads shocking patient on zm-521pa is isolated to this facility.As the reported issue was found to be only occurring at this facility and the device performed without issue on a calibrated simulator with new batteries, possible cause of the issue is user error.There is no suspected adverse trend and there is no indication of design deficiency.The device is low voltage and it is unlikely that the device contributed to shock.Investigation by qe has been completed and investigational information within the record documents that the device was performing as intended by manufacturer.The mdr initial report was not appropriately submitted to reflect that the patient suffered an adverse event of being shocked.The initial report only spoke towards a device malfunction.The final follow up report to fda addresses both the malfunction of the device and serious medical event involving the patient.Attempts to obtain patient information was unsuccessful due to the age of the incident.Corrected information: date received by manufacturer: should be 02/22/2018 not 03/22/2018 as listed on mdr initial report.Type of reportable event.Mdr initial marked as malfunction.It should also be marked as serious injury.As only one selection is allowed, updated to serious injury.Additional information: if follow-up, what type?: additional information, correction.The following fields contain no information (ni), as attempts to obtain information were made, but not provided:.

Event Description

The biomedical engineer reported that a telemetry patient claims he was shocked by the leads.

Manufacturer Narrative

Corrected data: device evaluated by manufacturer, event problem and evaluation codes, additional manufacturer narrative.Additional information: type of report: follow up, type of report: follow up, additional information/correction.Field required for submission.The biomedical engineer reported that a telemetry patient claims he was shocked by the leads.The bme states he does not have the leads and has no idea where the leads are.The nursing staff also does not know where the leads are.The bme reports that there is no physical damage or fluid intrusion.He states that the batteries were new in the device and the leads were a few months old.He tried the device on a simulator in his shop and there does not appear to be an issue.The patient has no injury and has been discharged.The unit has been exchanged under warranty and has be sent in for investigation.Qa investigation determined that the leads required for the investigation were not returned.The transmitter itself was found to be in good working order when new batteries were inserted.The device was evaluated for any signs of fluid intrusion and no signs were found.Given the device is low voltage and there were no signs of fluid intrusion, it is unlikely the device contributed to a shock.

• Brand Name: ZM-521PA
• 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: 7364516
• MDR Text Key: 103405213
• Report Number: 8030229-2018-00088
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• 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: 07/26/2019

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-531PA
• Device Catalogue Number: ZM-531PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2019
• Distributor Facility Aware Date: 07/11/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 03/22/2018; 07/11/2019
• Supplement Dates FDA Received: 05/01/2018; 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: LEADS
• Patient Outcome(s): Other