MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number ZM-541PA

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Issue (2379); Output Problem (3005)

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

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the transmitter is giving off inaccurate ecg readings.The customer changed the batteries, leads, and put it on a simulator.The device was returned to nihon kohden for evaluation.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.

Event Description

The customer reported that the transmitter is giving off inaccurate ecg readings.

Manufacturer Narrative

Complaint details: customer reported that their zm-541pa's ecg was giving incorrect readings.The transmitter was tested with different cables and a simulator, but the issue persisted.Service requested: exchange.Service performed: exchange the customer was sent an exchange unit to resolve the issue.The customer's defective unit was received.Defective unit cannot perform operation channel change.The unit was cleaned and evaluated.It had fluid intrusion and was contaminated.Scrap unit.Investigation result: the root cause of the issue was found to be customer mishandling the unit/customer abuse.Evidence of mishandling can be seen through the device having fluid intrusion.Fluid intrusion affects the device's internal components and can affect the overall function of the unit.Based on the given information, this issue is not suspected to be caused by deficient device or design.Corrected information: device available for evaluation? (date returned).

Event Description

The customer reported that the transmitter is giving off inaccurate ecg readings.

• Brand Name: ZM-541PA
• 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: 7646156
• MDR Text Key: 112852857
• Report Number: 8030229-2018-00239
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921106617
• UDI-Public: 04931921106617
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZM-541PA
• Device Catalogue Number: ZM-541PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2019
• Distributor Facility Aware Date: 10/01/2019
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1