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

Model Number ZM-530PA

Device Problems Use of Incorrect Control/Treatment Settings (1126); Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that the transmitter was warm to the touch during use on a patient.The reported device was returned to nihon kohden; however, device evaluation anticipated, but not yet begun.Nihon kohden continues to investigate the reported event and will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported that the transmitter was warm to the touch during use on a patient.No consequence or impact to the patient.

Manufacturer Narrative

Details of the complaint on (b)(6) 2018, customer at (b)(6) reported the transmitter (zm-530pa sn:(b)(6)) was warm to the touch.The bme was originally called for the unit having signal loss and when the transmitter was handed to them, the biomed felt that it was warm.Service requested exchange service performed exchange.Investigation result the transmitter was delivered to (b)(6) on (b)(6) 2018, which was 4 months prior to the reported issue.Review of device history found issue was previously reported: 300152060 reported (b)(6) 2018 in which device was reported to read signal loss and felt warm to the touch.The device started working by the time ts called bme.Qe evaluation of the unit (zm-530pa sn:5026) performed on 09/20/19: the batteries involved were not returned with the unit.The battery compartment appeared to be in good condition with no signs of damage, corrosion, or improper battery insertion.Upon proper insertion of batteries, the warmth could not be duplicated.Unit was able to turn on and transmit to the cns using ch9344.The channel label located at the front of the unit was found to not match the channel programmed into the unit.See attached picture zm530pasn5026_ch in which ch labeling indicates channel 9254 however the top left corner of the screen indicates unit is programmed to ch9344.The root cause of the signal loss is determined to be incorrect labeling of the channel.Zm-530pa operator's manual advises customer to not allow the transmitter to continuously contact the patient's skin directly, as the transmitter heats up by 2 or 3 degrees c during normal operation, which may cause low temperature burn to the patient.Temperature of the device may also be affected by its environment, such as temperature of the room, access to direct sunlight, or temperature of other equipment/personnel which may contact with the unit.The reported issue of "warm" transmitter is not suspected to be related to a deficiency of the device.No issue found with the transmitter.This issue is not suspected to be caused by deficiency of the device or its design.

Event Description

It was reported that the transmitter was warm to the touch during use on a patient.The bme was originally called for the unit having signal loss and when the transmitter was handed to them, the biomed felt that it was warm.No consequence or impact to the patient.

• 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: 8211017
• MDR Text Key: 131889094
• Report Number: 8030229-2019-00004
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

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-530PA
• Device Catalogue Number: ZM-530PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2019
• Distributor Facility Aware Date: 09/20/2019
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1