MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-130PA; TRANSMITTER

Model Number GZ-130PA

Device Problems No Audible Alarm (1019); Protective Measures Problem (3015)

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

Event Date 10/31/2013

Event Type  malfunction  

Event Description

The customer reported that the gz transmitter did not alarm for low battery at the central nurse's station (cns) before showing communication loss.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the gz transmitter did not alarm for low battery at the central nurse's station (cns) before showing communication loss.There was no patient injury 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.D10 concomitant medical device: the following device(s) was used in conjunction with the gz transmitter: model #:pu-681ra, serial #:(b)(6), device manufacturer data: 03/04/2021, unique identifier (udi) #: (b)(4), returned to nihon kohden: ni.

Event Description

The customer reported that the gz transmitter did not alarm for low battery at the central nurse's station (cns) before showing communication loss.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the gz transmitter did not alarm for low battery at the central nurse's station (cns) before showing communication loss.There was no patient injury reported.Investigation summary: a definitive root cause could not be determined as we did not receive the device for evaluation and the cns alarm logs would only confirm the lack of alarm.The customer replied in a follow-up on (b)(6) 2023 that they no longer needed a review of the logs.Nihon kohden qa explained the possible causes to the customer and the customer understood.D10 concomitant medical device: the following device(s) was used in conjunction with the gz transmitter: cns: model #:pu-681ra serial #:(b)(6) device manufacturer date: 03/04/2021 unique identifier (udi) #: 04931921131640 returned to nihon kohden: no additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h11 additional manufacturer narrative manufacturer references # (b)(4).Follow up 001.

• Brand Name: GZ-130PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 116-8 560; JA 116-8560
• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18233786
• MDR Text Key: 329329787
• Report Number: 8030229-2023-03885
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153707
• 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: 02/23/2024

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: GZ-130PA
• Device Catalogue Number: GZ-130PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2020
• 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: CNS; CNS
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander