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 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that they were conducting an operational test.When they inserted the batteries to test the unit, the device started to become warm.They stated that they noticed the batteries were inserted incorrectly with the terminals being connected across both batteries (suspect the batteries were shorted).Tech support (ts) requested that the customer take a picture of the batteries and send to nihon kohden.Found at set up and not in patient use.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 (bme) reported that they were conducting an operational test.When they inserted the batteries to test the unit, the device started to become warm.They stated that they noticed the batteries were inserted incorrectly with the terminals being connected across both batteries (suspect the batteries were shorted).Tech support (ts) requested that the customer take a picture of the batteries and send to nihon kohden.Found at set up and not in patient use.

Event Description

The biomedical engineer (bme) reported that they were conducting an operational test.When they inserted the batteries to test the unit, the device started to become warm.They stated that they noticed the batteries were inserted incorrectly with the terminals being connected across both batteries (suspect the batteries were shorted).Tech support (ts) requested that the customer take a picture of the batteries and send to nihon kohden.Found at set up and not in patient use.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that they were conducting an operational test.When they inserted the batteries to test the unit, the device started to become warm.They stated that they noticed the batteries were inserted incorrectly with the terminals being connected across both batteries (suspect the batteries were shorted).Tech support (ts) requested that the customer take a picture of the batteries and send to nihon kohden.Found at set up and not in patient use.Investigation conclusion: heating of the battery may occur to improper installation of the batteries on the device.The (-) end of the battery must be inserted first and should press against the spring in order to avoid deformation of the battery and the spring of the transmitter.User indicated that they had not properly positioned the battery and the warming of the device occurred.Furthermore, nk repair center was unable to duplicate the issue.Based on the available information, the most probable cause of the issue is user error.The operator's manual for zm-520/521/530/531 provides instructions on how to properly insert batteries into the transmitters.A visual representation of the battery insertion process can also be found in mtbex 067a.The issue is related to user error.If the user had inserted the batteries properly and followed the operator's manual, the issue would have not occurred.Nk repair center was also unable to duplicate the issue.Additional information: b4 date of this report d9 device available for evaluation g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer h6 event problem and evaluation codes h10 additional manufacturer narrative.

• 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: 13657268
• MDR Text Key: 289358373
• Report Number: 8030229-2021-02610
• 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
• Report Date: 06/13/2022

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-531PA
• Device Catalogue Number: ZM-531PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 06/07/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• 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