MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION GZ-120PA; TRANSMITTER

Model Number GZ-120PA

Device Problems Power Problem (3010); Intermittent Loss of Power (4016)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the gz telemeter's battery contact was broken, causing the telemeter to lose power intermittently.

Event Description

The biomedical engineer reported that the gz telemeter's battery contact was broken, causing the telemeter to lose power intermittently.

• Brand Name: GZ-120PA
• 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
• MDR Report Key: 11516611
• MDR Text Key: 247393454
• Report Number: 2080783-2021-00157
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921117392
• UDI-Public: 04931921117392
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/18/2021

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-120PA
• Device Catalogue Number: GZ-120PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Distributor Facility Aware Date: 02/24/2021
• Device Age: 38 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1