MAUDE Adverse Event Report: CAREFUSION HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100A

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 09/09/2013

Event Type  malfunction  

Manufacturer Narrative

This initial report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.(b)(4).Mfg date: date is not available.The part/model#- 768901-rnt serial #- (b)(4) was received by carefusion factory service; found unit missing pedestal leg and caster, water traps damaged which required replacement.Also noted found driver cover with hole through it, main chassis damaged.Replaced effected components.The reported condition was verified.

Event Description

The customer reported, vent suffered extensive damage from falling down (onto back).Both watertraps are broken.He noticed that one of the caster wheels was broken (bent).Customer detailed needing the replacement vent urgently because the one they received has to be replaced.He explained that they received the rental vent and calibrated it.Everything passed and they were transferring it to the nicu.As the vent was rolling down the hallway, one of the "caster wheels became loose causing the vent to fall down".He reports that both the watertraps were damaged.He states that because of this incident, there is a delay in treatment for this patient that really needs the 3100a.Patient status is unknown.

• Brand Name: HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): CAREFUSION; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: jill rittorno ; 7149227830
• MDR Report Key: 5415664
• MDR Text Key: 38127925
• Report Number: 2021710-2016-02977
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768901-RNT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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