MAUDE Adverse Event Report: FISHER AND PAYKEL HEALTHCARE LTD. FISHER PAYKEL; VENTILATOR, NON - CONTINUOUS (RESPIRATOR)

Model Number BC191

Device Problems No Pressure (2994); Material Split, Cut or Torn (4008)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 06/24/2019

Event Type  Injury  

Event Description

The fisher paykel cpap connection tore at the membrane resulting in a loss of bubble cpap pressure, causing patient to brady/desat with a 2 minute return to baseline following interventions.This was an unprovoked tear between care times, with no applied pressure to the device.

• Brand Name: FISHER PAYKEL
• Type of Device: VENTILATOR, NON - CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): FISHER AND PAYKEL HEALTHCARE LTD.
• MDR Report Key: 8855517
• MDR Text Key: 153401813
• Report Number: MW5088651
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC191
• Device Catalogue Number: BC191
• Device Lot Number: 210682116
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR