MAUDE Adverse Event Report: NIHON KOHDEN TOMIOKA CORPORATION AG-920RA; MULTI-GAS UNIT

Model Number AG-920RA

Device Problem Device Inoperable (1663)

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

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the multi-gas unit gives low readings, and shows artifact wave forms and unusual breath rates.The device was returned to nihon kohden, evaluated, and the reported issue was confirmed.The unit had noisy wave forms (artifacts) and was making a loud buzzing sound.The internal gas unit was replaced to fix this issue.All functions were tested per service manual after the repair.The repaired unit was returned to the customer.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 multi-gas unit gives low readings, and shows artifact wave forms and unusual breath rates.

• Brand Name: AG-920RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn; susan shadley; tomioka city, japan 370-2 314; JA 370-2314
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer Contact: susanxx shadley ; 1-31-4 nishiochiai, shinjuku-k; attn: susan shadley; tokyo, japan 161-8-560 ; JA 161-8560 ; 2687133
• MDR Report Key: 5573872
• MDR Text Key: 42543564
• Report Number: 8030229-2016-00147
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/13/2016,03/14/2016

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: AG-920RA
• Device Catalogue Number: AG-920RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2016
• Distributor Facility Aware Date: 03/14/2016
• Device Age: 118 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2016
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1