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

Model Number ORG-9110A

Device Problems Signal Artifact/Noise (1036); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

The customer's contractor reported that the multiple patient receiver (org) was having intermittent signal loss and dropouts in a certain area of the hospital.It is happening in rooms 318-321 only and is gradually getting worse.No patient harm reported.Nihon kohden field service technician went to facility and replaced a power supply which resolved the issue.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.Attempt # 1: (b)(6) 2021 emailed the customer via (b)(6) for patient information: no reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via (b)(6) for patient information: reply was received, customer did not have any further information on any patient(s) demographics or additional device(s) in use at the time of the event.Attempt # 1: (b)(6) 2021 emailed the customer via (b)(6) for patient information: no reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via (b)(6) for patient information: reply was received, customer was not able to provide any further information on any patient(s) demographics or additional device(s) in use at the time of the event.Attempt # 1: (b)(6) 2021 emailed the customer via (b)(6) for patient information: no reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via (b)(6) for patient information: reply was received, customer was not able to provide any further information on any patient(s) demographics or additional device(s) in use at the time of the event.Concomitant medical device: attempt # 1: (b)(6) 2021 emailed the customer via (b)(6) for additional device information: no reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via (b)(6) for additional device information: reply was received, customer was not able to provide any further information on any additional device(s) in use at the time of the event.

Event Description

The customer's contractor reported that the multiple patient receiver (org) was having intermittent signal loss and dropouts in a certain area of the hospital.It is happening in rooms 318-321 only and is gradually getting worse.No patient harm reported.

Manufacturer Narrative

The customer's contractor reported that the multiple patient receiver (org) was having intermittent signal loss and dropouts in a certain area of the hospital.It is happening in rooms 318-321 only and is gradually getting worse.No patient harm reported.Nihon kohden field service technician went to facility and replaced a power supply which resolved the issue.Investigation summary: the customer reproted that an nihon kohden field service technician was able to resolve the issue after replacing the power supply.It is likely that the power supply for the antennas were malfunctioning.Since the org has been installed at the customer's facility since 03/2012, as such the root cause of intermittent signal loss is most likely power supply failure due to wear and tear.There is no indication that the signal loss was occurring due to a deficiency in design or manufacturing of the org as such a corrective action or preventative action is not warranted.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: 07/07/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 07/08/2021 emailed the customer via microsoft outlook for patient information: reply was received, customer did not have any further information on any patient(s) demographics or additional device(s) in use at the time of the event.B6 attempt # 1: 07/07/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 07/08/2021 emailed the customer via microsoft outlook for patient information: reply was received, customer was not able to provide any further information on any patient(s) demographics or additional device(s) in use at the time of the event.B7 attempt # 1: 07/07/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 07/08/2021 emailed the customer via microsoft outlook for patient information: reply was received, customer was not able to provide any further information on any patient(s) demographics or additional device(s) in use at the time of the event.Additional device information: d10 concomitant medical device: attempt # 1: 07/07/2021 emailed the customer via microsoft outlook for additional device information: no reply was received.Attempt # 2: 07/08/2021 emailed the customer via microsoft outlook for additional device information: reply was received, customer was not able to provide any further information on any additional device(s) in use at the time of the event.

Event Description

The customer's contractor reported that the multiple patient receiver (org) was having intermittent signal loss and dropouts in a certain area of the hospital.It is happening in rooms 318-321 only and is gradually getting worse.No patient harm reported.

• 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 ; 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: 12170917
• MDR Text Key: 268506848
• Report Number: 8030229-2021-00410
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• 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: Other,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

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-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 06/01/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2011
• 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