MAUDE Adverse Event Report: BUNNELL, INC. BUNNELL; LIFE PULSE HFV

Model Number 203A

Device Problems Loose or Intermittent Connection (1371); Device Maintenance Issue (1379); Blocked Connection (2888)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2014

Event Type  malfunction  

Event Description

(b)(6) called to report that they got a high water level alarm.They did some troubleshooting and decided to change the circuit.The new circuit generated a high level alarm as well.Water overfilled the cartridge and water entered the circuit.They took the pt off the life pulse, thinking this might be a ventilator/humidifier issue.The pt was stabilized by manual resuscitation (bagging) while the ventilator was switched out.They used the same circuit on the new ventilator and everything worked properly.(b)(6), one of (b)(6) biomed techs, said was able to duplicate the complaint of water overfill.He said the cartridge housing lid was loose, allowing the cartridge to move around.He tightened the screws holding lid in place, then retested the system using one of the circuits involved in the complaint.The cartridge filled normally and no alarms were generated.He felt confident that the loose lid/door caused the problem.The pt was stabilized by hand bagging while the ventilator was switched out.He was placed on the new life pulse hfv without injury.

Manufacturer Narrative

(b)(6) was contacted for some follow-up info.He said that he fixed the cartridge lid by tightening the screws and demonstrated to the respiratory therapist, (b)(6), that the circuits in question, for overfill, filled properly, and the vent and humidifier functioned appropriately.(b)(6) said if the vent was fixed and the circuits were not to blame then don't send them back to bunnell.(b)(6) discarded the circuits without recording the lot#s.No circuits or other equipment was returned to bunnell for evaluation.The customer was confident that their biomed department had resolved the issue and there was no need for bunnell to evaluate the equipment.The pt suffered no injury, and was returned to treatment on a new life pulse hfv.

• Brand Name: BUNNELL
• Type of Device: LIFE PULSE HFV
• Manufacturer (Section D): BUNNELL, INC.; salt lake city UT
• Manufacturer Contact: curtis olsen ; 436 lawndale dr.; salt lake city, UT 84115 ; 8014670800
• MDR Report Key: 3784491
• MDR Text Key: 4432365
• Report Number: 1719232-2014-00001
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/24/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 203A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/1989
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention