MAUDE Adverse Event Report: ZM-541PA; TELEMETRY TRANSMITTER

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

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

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Awaiting requested device for repair and failure investigation.

• Brand Name: ZM-541PA
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer Contact: 1-31-4 nishiochia,shinjuku-ku; tokyo 161-8-560 ; 7050350
• MDR Report Key: 4173576
• MDR Text Key: 20751771
• Report Number: 8030229-2014-00047
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Remedial Action: Other
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1