MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9100A

Device Problems Communication or Transmission Problem (2896); Device Operational Issue (2914)

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

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the org was in signal loss on two tele devices.After some troubleshooting, it was decided that they would switch the org out for a known working one, which resolved the issue.The failure was found to be with two receivers on the failed org device.No patient harm was reported.

Event Description

The biomedical engineer reported that the org was in signal loss on two tele devices.

Manufacturer Narrative

Details of complaint: on (b)(6) 2018 customer reported signal loss on two tiles on the cns.These tiles correspond to tele 19 and 23.An org receiver device receives signal from up to 8 transmitters.Each transmitter corresponds to a receiver card on the org device.After isolating the issue to just two receiver cards, customer was provided with part number for replacement.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: the org device was put into service on 8/12/2009.Service history shows no other incidents.Org-9100 service manual, 9th edition, listed major maintenance check on the device.It includes checking the receiver sensitivity.This should be done a minimum yearly to ensure degradation or loss of function do not go unnoticed.Zr-920p is a replaceable part.The maintenance for this org device is not available.The age of the two receiver cards (zr-920p) is unknown.Thus, the root cause of the failure could not be determined.Additional information: b4.Date of this report; d11.Concomitant medical products; 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; h3.Device evaluated by manufacturer? h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.The following fields are not applicable (n/a) to this report: a2 - a6; b2; b6; b7; d4 lot # & expiration date; d6 - d7; d9; f10; g6; g8; h7; h9.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: d11& c2: two transmitters (tele 19 & tele 23) were used on the org, however no model/serial for each transmitter was provided.

Event Description

The biomedical engineer reported that the org was in signal loss on two tele devices.

• Brand Name: ORG-9100A
• 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: 7249642
• MDR Text Key: 99313498
• Report Number: 8030229-2018-00037
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• 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: 10/23/2019

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: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2019
• Distributor Facility Aware Date: 10/04/2019
• Device Age: 109 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2019
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: 2 TRANSMITTERS.