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 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter became hot.The nurse removed the unit to investigate and found one of the procell batteries had began to peel.The biomedical engineer replaced the batteries and tested the unit for one week and found no issues.The unit was not returned for further analysis as the biomedical engineer determined that the incident occurred as a result of a bad battery.

Event Description

The customer reported that the transmitter became hot.

Manufacturer Narrative

On (b)(6) 2018, (b)(6) at (b)(6) medical center reported the transmitter (zm-930pa sn:(b)(4)) was heating up.No one was injured by this device.Service requested.Troubleshooting/assistance.Service performed.Customer felt no need to send the device in.They used the device with replacement batteries and verified the transmitter had no issues.Investigation result: the device warranty began 2007, which is almost 11 years at the time of reported issue.A review of device history found no previously reported issues with the device overheating.A review of customer's complaints found no similarly reported issues with a telemetry device overheating.As the device was not returned, evaluation of the unit could not be performed.A trend analysis for zm-930pa and keyword "hot" using qa report found one similarly reported issue: ticket #(b)(4) reported (b)(6) 2018 in which the transmitter (zm-930pa sn:(b)(4)) was reported to get hot.However, issue was unable to be duplicated.The occurrence of 2 total incidents reported for the transmitter zm-930pa between 2017-2019, neither of which were able to reproduce the reported issue, does not represent an adverse trend.Customer reported there was no issue with the transmitter.Customer reported no further issues with the unit as of 05/09/2019.The root cause is determined to be use error/battery issue.There is no indication of deficient device or design.The device was in use on a patient and there was no reported patient harm.Corrected information: date received by manufacturer: should be 06/21/2018 not 07/17/2018 as listed on mdr initial report.

Event Description

The customer reported that the transmitter became hot.

• 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: 7695257
• MDR Text Key: 114331379
• Report Number: 8030229-2018-00268
• 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: 07/17/2018
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Distributor Facility Aware Date: 05/09/2019
• Device Age: 131 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2019
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1