MAUDE Adverse Event Report: BIO-MED DEVICES BIO-MED DEVICES; TRANSPORT VENTILATOR

Model Number IC-2A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Swelling (2091); Injury (2348)

Event Date 05/20/2017

Event Type  No Answer Provided  

Event Description

At user facility, an mr-conditional transport ventilator was removed from its mr-conditional stand (contrary to the ifu's stated mr use conditions) and put on the patient's lap during an mri procedure.The ventilator was then pulled toward the chamber wall and the therapist's hand was injured (swelling only, apparently minor).There was no patient harm or injury.This ventilator had been in use at this facility for years with no prior incidents or complaints.This ventilator is an all-pneumatic transport ventilator, with no electronic parts.This ventilator has not been returned to the manufacturer for service since 2011.

Manufacturer Narrative

Upon return to the manufacturer, it was found that the user facility had installed its own electronic tracking device, an apparent rfid electronic module labelled "teletracking" model # rf-715 (b)(4) onto the side of the ventilator.This adulteration compromised the mr-conditional aspect of the ventilator.The module was tie-wrapped to a carrier bracket installed by the user; the ventilator manufacturer bio-med devices has never before seen either of these two items, and certainly did not authorize this installation by the user.The teletracking module had a battery inside (not appropriate for mri room).Also, the installation pin in the center of the carrier bracket was found to be strongly magnetic.The manufacturer removed these two items from the ventilator, and will not be sending either the module or the carrier bracket back to the user when we return their ventilator (the ventilator has been restored to its proper mr-conditional original physical condition).The manufacturer has notified the user facility (alerting both the equipment tech who routed this ventilator, and their director of respiratory care) that they need to examine all of their mr-safe and mr-conditional equipment at their facility, to be sure that teletrackers were not attached to any other equipment that they might bring into their mri rooms.

Event Description

At user facility, an mr-conditional transport ventilator was removed from its mr-conditional stand (contrary to the ifu's stated mr use conditions) and put on the patient's lap during an mri procedure.The ventilator was then pulled toward the chamber wall and the therapist's hand was injured (swelling only, apparently minor).There was no patient harm or injury.This ventilator had been in use at this facility for years with no prior incidents or complaints.This ventilator is an all-pneumatic transport ventilator, with no electronic parts.This ventilator has not been returned to the manufacturer for service since 2011.

• Brand Name: BIO-MED DEVICES
• Type of Device: TRANSPORT VENTILATOR
• Manufacturer (Section D): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• Manufacturer (Section G): BIO-MED DEVICES; 61 soundview rd; guilford CT 06437
• Manufacturer Contact: ken close ; 61 soundview rd; guilford, CT 06437 ; 2034580202
• MDR Report Key: 6712494
• MDR Text Key: 164427241
• Report Number: 1218704-2017-00002
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Service and Testing Personnel
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Respiratory Therapist
• Device Model Number: IC-2A
• Device Catalogue Number: 8001M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1