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

Model Number ZM-930PA

Device Problem Overheating of Device (1437)

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

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the transmitter heated up when being used on a patient but there was no patient harm or incident.The bme tested the unit and could not replicate the overheating.An exchange device was sent to the customer and the transmitter was returned to nihon kohden for evaluation.It is pending qa 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 the transmitter heated up when being used on a patient but there was no patient harm or incident.

Manufacturer Narrative

H10: additional narrative: on 06/22/18, (b)(6) medical center reported the transmitter (zm-930pa sn:(b)(6) ) heated up when used on a patient.There was no patient harm or incident.Ramez had been testing the unit in the bme office for about 30 minutes and the unit was not heating up.Service requested: exchange.Service performed: exchange.Investigation result: the device warranty began 2011, which is over 7 years at the time of reported issue.A review of device history found no previously reported issues with the device.A review of customer's complaints found no similarly reported issues with a telemetry device overheating.Qa evaluation was unable to duplicate the reported issue of transmitter heating up upon insertion of the batteries.The reported issue could not be duplicated by both biomed at the customer's facility and qa evaluation at nka.A trend analysis for zm-930pa and keyword "hot" using qa report found one similarly reported issue: ticket #33698 reported 07/11/18 in which the transmitter (zm-930pa sn:(b)(6) ) was reported to heat up.However, customer later reported issue was not with the transmitter but with the battery.The occurrence of 2 total incidents reported for the transmitter zm-930pa, neither of which were able to reproduce the reported issue, does not represent an adverse trend.The root cause is determined to be use error.There is no indication of deficient device or design.The device was in use on a patient and there was no reported patient harm.Per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.

Event Description

The biomedical engineer reported that the transmitter heated up when being used on a patient but there was no patient harm or incident.

• 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: 7708476
• MDR Text Key: 114679929
• Report Number: 8030229-2018-00275
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Distributor Facility Aware Date: 08/20/2019
• Device Age: 91 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1