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

Model Number ORG-9110A

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this org has defective receiver cards and they want to send in the unit to be repaired.Technical support (ts) informed the customer that a po will be required as the unit is out of warranty.There was no patient injury reported.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

The customer reported that this org has defective receiver cards and they want to send in the unit to be repaired.There was no patient injury reported.

Event Description

The customer reported that the multi patient receiver (org) had defective receiver cards and they wanted to send the unit in for repair.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the multi patient receiver (org) had defective receiver cards and they wanted to send the unit in for repair.No patient harm was reported.Investigation summary: the reported device was sent in for repair.During the evaluation of the reported device, nihon kohden repair center (nk rc) was able to confirm the reported issue of defective receiver cards.Failure of receiver cards is likely a result of hardware failure.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or device placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.The org was installed in 9/2012 with no history of previous complaints or servicing.The root cause is likely related to aging of the device.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided.Attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: the customer replied by stating that it's hard to answer all the questions as this issue has been happening intermittently all over that floor with different patients at different times.Additional information: b4 date of this report.D9 device available for evaluation? g3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

Event Description

The customer reported that the multi patient receiver (org) had defective receiver cards and they wanted to send the unit in for repair.There was no patient injury reported.

Manufacturer Narrative

Udi related data quality updates.Corrected information: d4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the pi information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14848194
• MDR Text Key: 302728038
• Report Number: 8030229-2022-02932
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: (01)04931921103906(21)292
• 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,Followup
• Report Date: 08/09/2024

1 Device 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: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/28/2022
• Supplement Dates Manufacturer Received: 10/02/2023; 10/02/2023
• Supplement Dates FDA Received: 10/03/2023; 08/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse