MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9700A; RECEIVER UNIT

Model Number ORG-9700A

Device Problems Signal Artifact/Noise (1036); Loss of Power (1475); Communication or Transmission Problem (2896)

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

Event Date 03/17/2022

Event Type  malfunction  

Event Description

The customer reported that the telemetry devices on the central nurse station (cns) went into communication loss.Nihon kohden technician had the customer go to the multiple patient receiver unit (org) and the customer found there were no lights on at the org.The customer verified that the org was plugged into an uninterruptible power supply (ups) device.Nihon kohden technician had the customer plug the org into a wall outlet and when they did the org came back on and the telemetry devices no longer showed communication loss but were displaying a signal loss message.Nihon kohden technician told the customer that the org unit was at its' end of life for servicing and can no longer be serviced.Nihon kohden technician recommended that the customer upgrade to a newer version org.No patient harm reported.

Manufacturer Narrative

The customer reported that the telemetry devices on the central nurse station (cns) went into communication loss.Nihon kohden technician had the customer go to the multiple patient receiver unit (org) and the customer found there were no lights on at the org.The customer verified that the org was plugged into an uninterruptible power supply (ups) device.Nihon kohden technician had the customer plug the org into a wall outlet and when they did the org came back on and the telemetry devices no longer showed communication loss but were displaying a signal loss message.Nihon kohden technician told the customer that the org unit was at its' end of life for servicing and can no longer be serviced.Nihon kohden technician recommended that the customer upgrade to a newer version org.No patient harm reported.Suspect medical device information: concomitant medical device: the following medical device(s) were used in conjunction with the org however the model and serial numbers are no information (ni) as attempts were made to obtain the information and no reply was received.Central nurse station: model #: ni.Serial #: ni.Telemetry transmitters: model #: ni.Serial #: ni.

Event Description

The customer reported that the telemetry devices on the central nurse station (cns) went into communication loss.Nihon kohden technician had the customer go to the multiple patient receiver unit (org) and the customer found there were no lights on at the org.The customer verified that the org was plugged into an uninterruptible power supply (ups) device.Nihon kohden technician had the customer plug the org into a wall outlet and when they did the org came back on and the telemetry devices no longer showed communication loss but were displaying a signal loss message.Nihon kohden technician told the customer that the org unit was at its' end of life for servicing and can no longer be serviced.Nihon kohden technician recommended that the customer upgrade to a newer version org.No patient harm reported.

Manufacturer Narrative

The customer reported that the telemetry devices on the central nurse station (cns) went into communication loss.Nihon kohden technician had the customer go to the multiple patient receiver unit (org) and the customer found there were no lights on at the org.The customer verified that the org was plugged into an uninterruptible power supply (ups) device.Nihon kohden technician had the customer plug the org into a wall outlet and when they did the org came back on and the telemetry devices no longer showed communication loss but were displaying a signal loss message.Nihon kohden technician told the customer that the org unit was at its' end of life for servicing and can no longer be serviced.Nihon kohden technician recommended that the customer upgrade to a newer version org.No patient harm reported.Investigation summary: as the device was not returned for evaluation, root cause cannot be determined.The device was in the customer's possession since 12/2003.Due to the age of the device being near 19 years old and with no history of servicing, it is likely that cause of the failure would be related to degradation due to aging.The (b)(6) has since been discontinued, the customer was advised to purchase a current model of org.As the cause of the comm loss/signal loss is likely related to the age of the device, further action is not warranted.The following fields are not applicable (na) to this report: b2 d4 lot #, expiration date, & udi # d6a & d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 attempt # 1: 04/11/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/13/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 04/14/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Suspect medical device information: d10 concomitant medical device: the following medical device(s) were used in conjunction with the org however the model and serial numbers are no information (ni) as attempts were made to obtain the information and no reply was received.Central nurse station: model #: ni serial #: ni telemetry transmitters: model #: ni serial #: ni manufacturer narrative: additional narrative/data b4: date of this report g3: date received by manufacturer g6: type of report h2: if follow-up, what type? h6: adverse event codes h10: additional manufacturer narrative.

• Brand Name: ORG-9700A
• Type of Device: RECEIVER UNIT
• 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: 14112776
• MDR Text Key: 289298220
• Report Number: 8030229-2022-02809
• Device Sequence Number: 1
• Product Code: DRG
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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-9700A
• Device Catalogue Number: MU-970RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2003
• 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
• Treatment: CENTRAL NURSE STATION (CNS); CENTRAL NURSE STATION (CNS); TELEMETRY TRANSMITTER; TELEMETRY TRANSMITTER