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

Model Number GZ-130PA

Device Problems Output Problem (3005); Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 08/13/2023

Event Type  malfunction  

Manufacturer Narrative

Details of the complaint: the biomedical engineer reported that the hi-q view ended for a gz telemetry transmitter (tele).The batteries died in the gz tele causing the hi-q view to end.They never received a "low battery or change battery" alert on the central nurse's station (cns).The batteries they were using are procell constant.They indicated the recommended batteries in our manuals (medipower are not available anymore in the us) and (nimh rechargeable batteries are not easy to accomodate with the facility).No patient harm was reported.Investigation conclusion: it was concluded that the two probable causes for no alarm for low battery are related to use of unspecified batteries.The batteries recommended in the operator's manual of the gz-130p are the only batteries that were verified to operate well with the device.The internal resistance of the battery will determine how well it operates with the gz-130p, and it cannot be determined with battery specifications alone.Root cause has been identified as the use of non-specified batteries.Central nurse's station: model: ni.Sn: ni.Device manufacturer date: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Bedside monitor: model: csm-1901a.Sn: (b)(6).Device manufacturer date: 09/04/2020.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

Event Description

The biomedical engineer reported that the hi-q view ended for a gz telemetry transmitter (tele).The batteries died in the gz tele causing the hi-q view to end.They never received a "low battery or change battery" alert on the central nurse's station (cns).The batteries they were using are procell constant.They indicated the recommended batteries in our manuals (medipower are not available anymore in the us) and (nimh rechargeable batteries are not easy to accomodate with the facility).No patient harm was reported.

• 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: 17845736
• MDR Text Key: 324617900
• Report Number: 8030229-2023-03778
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117415
• UDI-Public: 04931921117415
• 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
• Report Date: 09/29/2023

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: 09/01/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• 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'S STATION; CSM-1901A SN (B)(6)