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

Model Number ORG-9100A

Device Problems Device Operational Issue (2914); Device Sensing Problem (2917)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they have been experiencing intermittent signal loss on their multiple patient receiver, org device.Customer tried to resolve the issue by switching out the transmitter as the issue was occurring on a specific transmitter.It was later noticed that the issue was occurring on all transmitters on the org.Additionally, there have been 5 second signal loss issues on the transmitters.Customer tested all other org's and the issue seems to be with this specific org.Customer was sent a loaner org, however will be returning the loaner as this issue is still occurring even with the loaner.The biomedical engineer states that this issue has been ongoing for months and has been affecting the 2nd and 3rd floors at the hospital.He believes this issue is being caused by their old antenna system on these floors.They recently completed a new install telemetry expansion and this new install with the new antenna system has had no issues.The customer would like to send the device in for evaluation so they now what steps to take next.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 they have been experiencing intermittent signal loss on their multiple patient receiver, org device.

Manufacturer Narrative

Corrected data: device available for evaluation, device evaluated by manufacturer, additional manufacture narrative.Additional information: reporter name and address, type of report?, type of report: if follow-up, what type?, event problem and evaluation codes.The customer reported that they have been experiencing intermittent signal loss on their multiple patience receiver, org device.Customer tried to resolve the issue by switching out the transmitter as the issue was occurring on a specific transmitter.It was later noticed that the issue was occurring on all transmitters on the org.Additionally, there have been 5 second signal loss issues on the transmitters.Customer tested all other org's and the issue seems to be with the specific org.Customer was sent a loaner org, however she returned the loaner as this issue is still occurring even with the loaner.The biomedical engineer states that this issue is being caused by their old antenna system on these floors.David cole was deployed onsite to evaluate the site's antenna system.

• 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, japan 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 ; 2687488
• MDR Report Key: 6616494
• MDR Text Key: 76836007
• Report Number: 8030229-2017-00167
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• 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: 06/06/2017,05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 06/06/2017
• Distributor Facility Aware Date: 05/10/2017
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2009
• 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