MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120PA; TRANSMITTER

Model Number GZ-120PA

Device Problems Defective Alarm (1014); Device Sensing Problem (2917); Appropriate Term/Code Not Available (3191)

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

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

The product involved in this event has not been returned to date to allow for an analysis to be performed.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if the product is returned for evaluation or new information is obtained.

Event Description

The customer reported that the gas unit is not getting a waveform for the co2 gas.Customer would like to send the unit in for evaluation.

Manufacturer Narrative

Corrected data event problem and evaluation codes.Additional manufacturer narrative.Additional information: follow up.Additional information/correction.Field required for submission.Additional manufacturer narrative: the customer reported that the patient should have alarmed v-fib, the nurses reported that both the bedside monitor (bsm) and the central nurse's station (cns) did not alarm.The customer sent an email containing pictures of the requested patient information by the clinical team.Kelly reviewed the pictures and could see v-fib and tachycardia but the unit did not alarm.The issue was escalated to the qa team where it was confirmed that the unit failed to alarm.Three attempts have been made to obtain additional information from the customer with no response.

Event Description

The customer reported that the gas unit is not getting a waveform for the co2 gas.Customer would like to send the unit in for evaluation.

Manufacturer Narrative

Details of complaint: on 7/23/2018 customer stated that the gas unit did not give co2 waveform.Device was sent to nka for evaluation and repair.On 9/17/2018 nka repair center evaluated the device.Device displayed "gas device error".This was diagnosed as sensor unit cd-314p-01 on 1/16/2020 nka repair center re-evaluated the device.The same observation was noted.Service requested: evaluation and repair.Service performed: evaluation.Investigation result: device was put into service 5/28/2015.Service history for this device shows the following: 07/23/2018 300132516 - reported the same day as the current notification.Customer stated user pulled the cable hard enough to break it apart.07/23/2018 300132506 - current notification.Information necessary for investigation was not available, specifically: water trap replacement frequency gas settings on bedside monitor.For example, if the screen layout on the bedside monitor is set to fixed mode, are the parameter settings properly configured? verification of proper connection for the water trap and sampling line are the gas units positioned at a permanent location or frequently moved? if frequently moved, is the multi-link connection cable next to the grounding terminal securely seated with two screws tightened? are there any bents on the exhaust gas tube? does the bacterial filter, where the exhaust tube is connected to, conform to 0.2 micrometer pore size? are the units stored in high humidity locations? is there adequate space behind the unit for the fan to operate properly? are there any units placed vertically? if so, did customer orientate the water trap according to manual's instruction? service manual for gf-210r/220r, second edition, printed 2012/09/21 includes the following selected items: general handling precautions: instrument must receive expert, professional attention for maintenance and repairs.When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order.Instrument and parts must undergo regular maintenance inspection at least every 6 months.If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.Per service manual, regular maintenance and inspection must be performed every six months.The "gas device error" was attributed to sensor unit cd-314p-01 failure.This repair could not be performed at nka.With little information provided regarding customer's maintenance of the device, the root cause of the sensor failure could not be determined.A review of manufacturer's device history record shows no nonconforming report, no deviation and no corrective and preventative actions associated with this device.Investigation conclusion: the "gas device error" was attributed to sensor unit cd-314p-01 failure.This repair could not be performed at nka.With little information provided regarding customer's maintenance of the device, the root cause of the sensor failure could not be determined.

• Brand Name: GZ-120PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 7438727
• MDR Text Key: 117850542
• Report Number: 8030229-2018-00331
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (y/n): N
• PMA/PMN Number: K153707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2020

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: GZ-120PA
• Device Catalogue Number: GZ-120PA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2020
• Distributor Facility Aware Date: 01/17/2020
• Device Age: 42 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2020
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 07/23/2018; 01/17/2020
• Supplement Dates FDA Received: 04/17/2018; 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1