MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-930PA

Model Number ZM-930PA

Device Problems Device Alarm System (1012); Incorrect Interpretation of Signal (1543); Improper Alarm (2951)

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

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the transmitter is reporting tachycardia instead of vfib.She tested the device on a simulator but could not reproduce the issue.Nihon kohden technical support advised the bme to copy the setting of a known working tile to the tile for the device in question.No 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 reported that the transmitter is reporting tachycardia instead of vfib.

Manufacturer Narrative

H10: additional narrative: (b)(6) reported on(b)(6) 2018 that their zm-930pa s/n (b)(6) displayed tachycardia instead of vfib.The customer informed technical support that the unit reported vitals and waveforms as designed when tested on a simulator.The nursing staff replaced the lead and there were no signs of physical damage or fluid intrusion.Support advised that the customer copy the setting of a known working tile to the tile for the device on the cns as the transmitter appeared to not have any issues.Service requested: troubleshooting.Service performed: troubleshooting.The customer reported that they got rid of the old nk equipment.Investigation result(s): root cause of the incorrect alarm issue was unable to be identified as the customer did not provide details regarding settings, the transmitter was performing as intended, and the device(s) in question could not be obtained for evaluation/investigation.Possible cause for the issue is user error or incorrectly configured device settings.Per the customer's email, the unit along with the other old nk equipment at the customer's facility has been disposed of.Warranty for the transmitter ended 06/22/2012 and the issue was reported 6 years after the end of warranty date.The device serial number history for the cns shows that there have been no previously reported issues nor servicing for incorrect alarm.Trending analysis found no similarly reported issues regarding zm-930pa displaying incorrect alarm.This indicates that the issue is isolated to this facility.An adverse trend is not suspected and there is no indication of design deficiency.Review of the device history record (dhr) shows that the unit has no history of ncmr, refurbishing, or other suspected defects (see attached).Further information is unattainable at this time and the reported device(s) cannot be obtained for investigation/evaluation, therefore investigation by qa has been completed.Corrected information: g4.Date received by manufacturer: should be 05/25/2018 not 06/21/2018 as listed on mdr initial report.

Event Description

The biomedical engineer reported that the transmitter is reporting tachycardia instead of vfib.

• Brand Name: ZM-930PA
• Type of Device: ZM-930PA
• 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: 7631632
• MDR Text Key: 112288943
• Report Number: 8030229-2018-00235
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: K946175
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

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-930PA
• Device Catalogue Number: ZM-930PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2019
• Distributor Facility Aware Date: 07/24/2019
• Device Age: 90 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2019
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1