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

Model Number ZM-520PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Incorrect Interpretation of Signal (1543); Invalid Sensing (2293); Device Sensing Problem (2917); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter is not getting correct readings.An exchange transmitter was sent to the customer, and the malfunctioning transmitter was shipped to nihon kohden for evaluation.The transmitter has been received and will be evaluated.No 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 if additional information becomes available.

Event Description

The customer reported that the transmitter is not getting correct readings.

Event Description

The customer reported that the transmitter is not getting correct readings.

Manufacturer Narrative

Details of the complaint on (b)(6) 2019, customer at (b)(6) hospital reported the transmitter (zm-520pa sn: (b)(6)) was not getting correct readings.Service requested exchange.Service performed exchange; nka repair center: replaced 7 o rings, 2 sealants.The unit was cleaned and evaluated, tested per the service manual.Completed the unit 24 hours of extended testing and operated to manufacturer's specifications.Investigation result per nkc dhr, the unit (zm-520pa sn: (b)(6)) 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.The transmitter warranty began 05/02/12.The reported issue occurred after approximately 6 years at the user facility.Review of device sap history found no previously reported issues with the unit.Similar tickets query using select keywords found the following related incidents: "zm-520pa readings" - 49453 reported at (b)(6) health for sn: (b)(6); investigation determined there was no malfunction of the device."zm-520pa reading" "zm-520pa incorrect" "zm-520pa wrong" - none found for incorrect readings due to the lack of information provided at the time of reported incident, details of the incorrect readings is unknown.Based on the available information, the root cause could not be determined.No adverse trend of "incorrect readings" for the zm-520pa was found.This issue is not suspected to be caused by deficient design.Unit was serviced by nka repair center and was tested to operate within specifications.Unit is currently at (b)(6) hospital with no issues 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: 7648783
• MDR Text Key: 112852981
• Report Number: 8030229-2018-00238
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

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-520PA
• Device Catalogue Number: ZM-520PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2019
• Distributor Facility Aware Date: 10/04/2019
• Device Age: 78 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2019
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.