MAUDE Adverse Event Report: MEDICALGORITHMICS POCKETECG; DETECTOR AND ALARM, ARRHYTHMIA

Device Problems Burst Container or Vessel (1074); Fire (1245); Charging Problem (2892)

Patient Problem No Information (3190)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

A patient was charging a removable battery for the ambulatory telemetry monitor when it exploded, causing a small fire on the patient's pillow on his bed.

• Brand Name: POCKETECG
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDICALGORITHMICS; 245 west 107th st.,; new york NY 10025
• MDR Report Key: 5060204
• MDR Text Key: 25118818
• Report Number: 5060204
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/04/2015,08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2015
• Event Location: Home
• Date Report to Manufacturer: 08/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR