MAUDE Adverse Event Report: INTERNATIONAL BIOMEDICAL, LTD. VOYAGER; INCUBATOR, NEONATAL TRANSPORT

Model Number VOYAGER

Device Problems Failure to Charge (1085); Loose or Intermittent Connection (1371); Smoking (1585)

Patient Problem No Information (3190)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

While removing old battery related to failure to charge because of open main fuse, as terminals were loosened, wiring harness shifted and went up in smoke.Biomed reviewed.Short from positive battery terminal to ground caused quick discharge of current.Contact was possibly made by tech's wrench.Tech says yes it did due to his reaction of the wire going up in smoke.

• Brand Name: VOYAGER
• Type of Device: INCUBATOR, NEONATAL TRANSPORT
• Manufacturer (Section D): INTERNATIONAL BIOMEDICAL, LTD.; 8508 cross park drive; austin TX 78754
• MDR Report Key: 3965835
• MDR Text Key: 4624124
• Report Number: 3965835
• Device Sequence Number: 1
• Product Code: FPL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: VOYAGER
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ITEM WAS NOT BEING USED ON A PATIENT.