MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-920PA; TELEMETRY TRANSMITTER

Device Problems Overheating of Device (1437); Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

Customer stated that the zm-920pa telemetry transmitter had intermittent signal loss.The device also gets hot while powered on.Not on a pt.Imp ref #(b)(4).

Manufacturer Narrative

Although the device was not on a pt, if the malfunction were to occur there is likelihood that a pt could suffer a skin burn.The intermittent signal loss is easily detected by the central monitoring system (cns) and if the malfunction should recur, it is not likely to cause or contribute to death or injury.Device repaired and returned to customer.

• Brand Name: ZM-920PA
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION
• Manufacturer Contact: 1-31-4 nishiochia, shinjuku-ku; tokyo 161-8-560 ; 7050350
• MDR Report Key: 4370530
• MDR Text Key: 5236830
• Report Number: 8030229-2014-00089
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: K945578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Type of Report: Initial
• Report Date: 11/21/2014

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: Other
• Initial Date Manufacturer Received: 11/28/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2003
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1