MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GF-210RA; MULTI-GAS UNIT

Model Number GF-210RA

Device Problems Loss of Power (1475); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

Biomedical engineer (b)(6) reported that his multi gas unit will suddenly stop working.He reports that it will produce gas readings and then will suddenly stop giving a reading.He has tried replacing the water trap and samples lines but the issue still persists.Nihon kohden technical support verified that the unit was powered on for at least an hour before putting it on patient use.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

Biomedical engineer reported that his multi gas unit will suddenly stop working.

Manufacturer Narrative

Additional manufacturer narrative: the biomedical engineer (bme) reported that his multi gas unit will suddenly stop working.He reports that it will produce gas readings and then will suddenly stop giving a reading.He has tried replacing the water trap and sample lines but the issue still persists.Nihon kohden technical support verified that the unit was powered on for at least an hour before putting it on patient use.Upon completion of the evaluation, it was determined that the only time the issue of "randomly stop producing readings" was duplicated was when the device was tested with a non-drager gas sample line.The repair center tested with multiple sample lines, all gave random readings to drop out and the o2 values also intermittently would drop out.Old sample line (part number yg-610p) is no longer used.New sample line (part number a/8290286) should be used.Old part number is known to cause the intermittent drop out.

• Brand Name: GF-210RA
• Type of Device: MULTI-GAS UNIT
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 6895970
• MDR Text Key: 87513354
• Report Number: 8030229-2017-00323
• Device Sequence Number: 1
• Product Code: CCK
• UDI-Device Identifier: 04931921106891
• UDI-Public: 4931921106891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110594
• 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,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-210RA
• Device Catalogue Number: GF-210RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 09/26/2017
• Distributor Facility Aware Date: 09/01/2017
• Device Age: 47 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2017
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• 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