MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-531PA; TRANSMITTER

Model Number ZM-531PA

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was on a patient when they noticed that the transmitter was getting hot, and they took the transmitter and removed the old batteries.When they removed the batteries, they were extremely hot.They also noticed that when they put new batteries in, the new batteries became really warm.Therefore, they removed the transmitter from service.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported that the telemetry transmitter was on a patient when they noticed that the transmitter was getting hot, and they took the transmitter and removed the old batteries.When they removed the batteries, they were extremely hot.They also noticed that when they put new batteries in, the new batteries became really warm.Therefore, they removed the transmitter from service.No patient harm was reported.Customer reported that their transmitter got hot.The complaint unit was returned by the customer, and it was evaluated by nk repair center.Nk repair center was unable to duplicate the heating complaint on the device.A previous investigation under (b)(4) identified that the incorrect insertion of the battery may cause the battery spring terminal to break the coating of the battery, leading to short circuit and eventually heating of the device.The battery used with the complaint was not returned and it could not be confirmed if it was damaged from improper battery insertion.Based on the available information, a definitive root cause could not be identified.However, as the issue occurred when used by the customer and was not duplicated by nk, a possible cause of the issue is improper battery insertion.The operator's manual provides instruction on how to properly insert the batteries on the device.Furthermore, a design change was made to prevent overheating by short circuit caused by improper insertion of batteries (ref tn-1231).The design change has been applied to the following serial numbers: (b)(4) - serial (b)(4) or later (b)(4) - serial (b)(4) or later (b)(4) - serial (b)(4) or later (b)(4) - serial (b)(4) or later.The complaint device zm-531pa sn (b)(4) was made prior to this change.Attempt #1 06/20/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 07/12/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 07/13/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the telemetry transmitter was on a patient when they noticed that the transmitter was getting hot, and they took the transmitter and removed the old batteries.When they removed the batteries, they were extremely hot.They also noticed that when they put new batteries in, the new batteries became really warm.Therefore, they removed the transmitter from service.No patient harm was reported.Investigation conclusion: customer reported that their transmitter got hot.The complaint unit was returned by the customer, and it was evaluated by nk repair center.Nk repair center was unable to duplicate the heating complaint on the device.A previous investigation under irc-nka300097945 identified that the incorrect insertion of the battery may cause the battery spring terminal to break the coating of the battery, leading to short circuit and eventually heating of the device.The battery used with the complaint was not returned and it could not be confirmed if it was damaged from improper battery insertion.Based on the available information, a definitive root cause could not be identified.However, as the issue occurred when used by the customer and was not duplicated by nk, a possible cause of the issue is improper battery insertion.The operator's manual provides instruction on how to properly insert the batteries on the device.Furthermore, a design change was made to prevent overheating by short circuit caused by improper insertion of batteries (b)(4).The design change has been applied to the following serial numbers: (b)(6) or later (b)(6)- serial( b)(6)or later (b)(6)- serial (b)(6) or later (b)(6).Serial (b)(6) or later.The complaint device (b)(4) sn (b)(6) was made prior to this change.The following fields are not applicable (na) to the mdr report: b2.D4 lot number & expiration.D6a - d6b.D7b.F1 - f14.G4 device bla number.G5.G7.H7.H9.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided.A2 - a6.B6 - b7.Attempt #1 06/20/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 07/12/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 07/13/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1 06/20/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 07/12/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 07/13/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional information: the following information applies for smdr 001 and smdr 002.B4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h10 additional manufacturer narrative.H11 corrected data.Corrected information: the manufacturer report number was reported incorrectly as.This should have been reported 8030229-2022-02956, but as this number cannot be changed and because we do not want to double report, we are informing the fda of the error in this smdr.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was on a patient when they noticed that the transmitter was getting hot, and they took the transmitter and removed the old batteries.When they removed the batteries, they were extremely hot.They also noticed that when they put new batteries in, the new batteries became really warm.Therefore, they removed the transmitter from service.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that the telemetry transmitter was on a patient when they noticed that the transmitter was getting hot, and they took the transmitter and removed the old batteries.When they removed the batteries, they were extremely hot.They also noticed that when they put new batteries in, the new batteries became really warm.Therefore, they removed the transmitter from service.No patient harm was reported.Investigation conclusion: customer reported that their transmitter got hot.The complaint unit was returned by the customer, and it was evaluated by nk repair center.Nk repair center was unable to duplicate the heating complaint on the device.A previous investigation under (b)(4) identified that the incorrect insertion of the battery may cause the battery spring terminal to break the coating of the battery, leading to short circuit and eventually heating of the device.The battery used with the complaint was not returned and it could not be confirmed if it was damaged from improper battery insertion.Based on the available information, a definitive root cause could not be identified.However, as the issue occurred when used by the customer and was not duplicated by nk, a possible cause of the issue is improper battery insertion.The operator's manual provides instruction on how to properly insert the batteries on the device.Furthermore, a design change was made to prevent overheating by short circuit caused by improper insertion of batteries (ref tn-1231).The design change has been applied to the following serial numbers: zm-520pa - serial (b)(6) or later zm-521pa - serial (b)(6) or later zm-530pa - serial (b)(6) or later zm-531pa - serial (b)(6) or later.The complaint device zm-531pa sn (b)(6) was made prior to this change.Corrected information: the manufacturer report number was reported incorrectly as 8030229-2021-02956.This should have been reported 8030229-2022-02956, but as this number cannot be changed and because we do not want to double report, we are informing the fda of the error in this smdr.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter was on a patient when they noticed that the transmitter was getting hot, and they took the transmitter and removed the old batteries.When they removed the batteries, they were extremely hot.They also noticed that when they put new batteries in, the new batteries became really warm.Therefore, they removed the transmitter from service.No patient harm was reported.

• Brand Name: ZM-531PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15033902
• MDR Text Key: 302864807
• Report Number: 8030229-2021-02956
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115107
• UDI-Public: 04931921115107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1