MAUDE Adverse Event Report: NIHON KOHDEN AMERICA, INC. NTX TRANSMITTER; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number ZM-541PA

Device Problem Product Quality Problem (1506)

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

Event Date 07/29/2016

Event Type  malfunction  

Event Description

This is a voluntary report to document what we perceive to be a weak design in the non-invasive bp connector on the nihon kohden ntx telemetry transmitter.In a step down unit, bps are not measured as often, so the hose is often removed from the transmitter and reconnected when a bp measurement is performed.Constant connection and reconnection of the hose tends to weaken the plastic female nibp connector that is on the transmitter.A slight leak tends to cause low readings which can impact patient care.The connector is obviously designed for convenience (quick connect and disconnect) but is susceptible to damage and quick wear and tear.We have implemented more frequent inspection procedures to reduce this possibility.Manufacturer response for telemetry monitor, ntx transmitter (per site reporter): the manufacturer sells replacement connectors which are easily replaced.During warranty, the connectors have been replaced at no charge.We have suggested that the connector be redesigned.

• Brand Name: NTX TRANSMITTER
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): NIHON KOHDEN AMERICA, INC.; 15353 barranca parkway; irvine CA 92618
• MDR Report Key: 5849533
• MDR Text Key: 51262357
• Report Number: 5849533
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: ZM-541PA
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2016
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1