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

Model Number ZM-531PA

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter battery compartment contacts melted due to overheating.No consequence or impact to the patient was reported.Nk will be sending the customer an exchange device to resolve the issue.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 customer reported that the transmitter battery compartment contacts melted due to overheating.No consequence or impact to the patient was reported.

Event Description

The customer reported that the contacts in the transmitter's battery compartment melted due to overheating.The device was not in patient use at the time.

Manufacturer Narrative

Details of complaint: the customer reported that the contacts in the transmitter's battery compartment melted due to overheating.The device was not in patient use at the time.Nihon kohden provided an exchanged device to resolve the issue.Service requested / performed: troubleshooting.Investigation summary: the rssi values for the transmitters being monitored by the central monitoring station were 15.Signal loss was able to be resolved by swapping out of one of the transmitters in signal loss.The transmitter in signal loss was most likely experiencing signal interference.The customer was advised to follow up but no follow up attempts were made by the customer.Root cause cannot be determined.As the root cause is likely to be caused by environment factors and there is no evidence of an nk device malfunction, a capa is not warranted.The following fields are not applicable (na) to the mdr report: b2, b6, b7, d4 lot # & expiration date, d6a & d6b, d7b, d10, f1 - f14, g4 device bla number, g5, g7, g8, h7, h9.Additional information: b4 date of this report, d8 was this device serviced by a third party?, 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: 9759601
• MDR Text Key: 194112118
• Report Number: 8030229-2020-00115
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/26/2020,08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2020
• Distributor Facility Aware Date: 02/13/2020
• Device Age: 50 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/04/2015
• 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