MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) is not alarming v-tach and the org multiple patient receiver provides the signal analysis from the transmitter. This is a use error issue as the appropriate leads were not used for arrythmia analysis and the recommendation was to use multi-read analysis or change trace 1 to ii lead and do single-read analysis. This is not a device failure. Nkc investigation: in single-lead analysis, some qrs complexes were not detected due to low amplitude, and the remaining qrs-detected beats were judged as the v-tach alarm did not occur. The average heart rate decreased slightly to about 72 bpm, but it did not alarm because bradycardia was set to 50 bpm or less. Therefore, it is determined that the v-tach alarm did not occur because trace 1 has low amplitude. Recommendation: use multi-read analysis or change trace 1 to ii lead and do single-read analysis.

Event Description

The customer reported that the central nurse's station (cns) is not alarming v-tach and the org multiple patient receiver provides the signal analysis from the transmitter.

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• 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, 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: 8614167
• MDR Text Key: 145241962
• Report Number: 8030229-2019-00154
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• 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: 07/25/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2019
• Distributor Facility Aware Date: 07/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2019
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NOT APPLICABLE