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

Model Number ORG-9110A

Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

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

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

They put a loaner in its place once they realized there was an issue.After checking the warranty status (which was no longer valid), they informed nk they will need to find another option for replacement.No patient harm was reported.Nihon kohden continues to investigate the reported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 biomedical engineer (bme) reported that the org had multiple receiver card failures, which occurred intermittently.

Event Description

The biomedical engineer (bme) reported that the org had multiple receiver card failures, which occurred intermittently.

Manufacturer Narrative

Details of complaint: on (b)(6) 2019 customer biomed reported device has multiple receiver cards with signal loss issues.The signal loss issue was occurring intermittently.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: org-9100a operator's manual, 18th edition, states that "the multiple patient receiver contains parts which gradually deteriorate with use.Original performance might not be delivered if any part is deteriorated.Perform regular maintenance checks to assure continued safe operation." periodic inspection is to be performed at least once a year.This inspection checks for the following items: 1.Receiver is not dirty, damaged, or rusty 2.Sockets on the receiver are not damaged 3.Lamps light correctly 4.Errors in communication in the network 5.Power cord is not damaged 6.Electrical current leakage maintenance information of the receiver is not available.Device was put into service on 4/23/2013.Service history shows the following: 300073923 reported on (b)(6) 2017, customer stated org receiver was experiencing intermittent signal loss.Upon evaluating the issue at nka, it was discovered that receiver was missing two cards.Only 6 of 8 receiver cards were present.No problems found with the 6 receiver cards.Thus, the issue could not be duplicated.Upon sending back the receiver to customer, customer claimed it was sent to nka with 8 cards installed.The claim could not be verified.The root cause could not be determined.Additional information: b4.Date of this report.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.H6.Event problem and evaluation codes h10.Additional manufacturer narrative.

• 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
• MDR Report Key: 8714648
• MDR Text Key: 149502418
• Report Number: 8030229-2019-00231
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2019
• Distributor Facility Aware Date: 09/11/2019
• Device Age: 78 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2019
• Date Manufacturer Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1