MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-521PA; TRANSMITTER

Model Number ZM-521PA

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the transmitter got overheated during patient monitoring activities.No consequence or impact to the patient was reported.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 got overheated during patient monitoring activities.No consequence or impact to the patient was reported.

Event Description

It was reported that the transmitter got overheated during patient monitoring activities.No consequence or impact to the patient was reported.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, biomed at (b)(6) hospital reported the transmitter (zm-521pa sn: (b)(6)) was overheating.Biomed tested the unit on a simulator for two hours and could not reproduce the phenomenon.Service requested/performed: nka technical support (ts) provided customer with documentation on battery insertion and specification.The customer was to continue testing the unit and review the provided documentation.3 attempts were made to follow up with the customer, receiving no response.Investigation result: per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.A review of device history found no previously reported issues with the device after release to the customer.Per nkc investigation performed under (b)(4) on a similarly reported incident, a possible cause of the overheating phenomenon may be incorrect battery insertion.Incorrect insertion of the battery causes the battery terminal spring to break the coating of the battery, leading to a short circuit.Investigation conclusion: the device was not returned to nka and no nka evaluation could be performed.Due to the lack of customer response, further information is not available, and the root cause could not be confirmed.The customer has not reported further issues with the unit.Corrected information: f9: approximate age of device.Changed from 7 months to 8 months.

• Brand Name: ZM-521PA
• 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: 8380443
• MDR Text Key: 137814711
• Report Number: 8030229-2019-00049
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115084
• UDI-Public: 4931921115084
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-521PA
• Device Catalogue Number: ZM-521PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2020
• Distributor Facility Aware Date: 01/22/2020
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2020
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1