MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-520PA; TRANSMITTER

Model Number ZM-520PA

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 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reports that the transmitter batteries will get very hot when put in the device and it will not turn on.No patient harm was reported.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 reports that the transmitter batteries will get very hot when put in the device and it will not turn on.No patient harm was reported.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019, the customer at medical center hospital reported that the transmitter (zm-520pa sn: (b)(6) appeared to be shorting out batteries.The batteries were reported to get very hot and the device would not power on.The customer reported the unit was repaired in the hospital.Service requested / performed: troubleshooting.Investigation summary: the unit was not returned and no nka evaluation was performed.The unit was reported to have been repaired by the bme at the facility.Additional information is not readily available as the bme was no longer with the facility.From the information available, the root cause is not known.Nkc investigation performed under irc-nka300097945 concluded that incorrect insertion of the battery may cause the battery terminal spring to break the coating of the battery, leading to a short circuit.Nkc conducted a test study to monitor temperature of the transmitter upon incorrect insertion of the battery.A design change has been introduced to the product to prevent short circuit of the battery.The overall risk, as determined from the product of probability (rare) and severity (minor), is determined to be low.

Event Description

The customer reports that the transmitter batteries will get very hot when put in the device and it will not turn on.No patient harm was reported.

• Brand Name: ZM-520PA
• Type of Device: TRANSMITTER
• 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: 9307254
• MDR Text Key: 170038435
• Report Number: 8030229-2019-00640
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115077
• UDI-Public: 04931921115077
• 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: 11/11/2019,11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-520PA
• Device Catalogue Number: ZM-520PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2019
• Distributor Facility Aware Date: 10/17/2019
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2019
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1