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

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

An exchange was sent to the customer.The battery protector on the right side of the battery compartment was melted due to the insulation wrapped around the battery had been damaged and came in contact with the plus battery contact.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of any product and this report only represents an enhancement to the reporting criteria going forward.

• Brand Name: ZM-920PA
• Type of Device: TELEMETRY TRANSMITTER
• Manufacturer Contact: 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8-560 ; 7050350
• MDR Report Key: 4385837
• MDR Text Key: 5263431
• Report Number: 8030229-2014-00123
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 08/08/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1