MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED RESPIRATORY HUMIDIFIER; BTT

Model Number	HC550JHU
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complaint hc550 humidifier is currently en route to fisher & paykel healthcare for evaluation.We are in process to determine if f&p's product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported that the power cord of an hc550 respiratory humidifier was damaged.The insulation and copper wires were exposed.There was no patient consequence reported.
Additional Manufacturer Narrative
Ps299607 method: photos of the complaint hc550 humidifier were provided, which were visually inspection.In addition, the customer stated that "it looks like the cover of the cord wore out and started showing the copper wires inside.I cut it to that point so it could not be used".Results: visual inspection of the provided photos revealed that the left over portion of the power cord was cut close to the unit.All three conductors on the device side of the power cord are exposed.However, there is no risk to a patient as it is not possible to connect the device to mains supply.Conclusion: the customer had intentionally cut the power cord to prevent re-use of the device.No photo of the complaint device was provided to show the unit before the power cord was intentionally cut.We are therefore unable to confirm the reported event.During initial assembly of the hc550 humidifier, all power cords are visually inspected for damage.Once the assembly process is completed, all devices are visually inspected again before release for distribution.This suggests the damage occured after it had been distributed.Our user instructions that accompany the hc550 humidifier state the following: - check accessories for any physical damage before use and replace if damaged.
Event or Problem Description
A healthcare facility in minnesota reported that the power cord of an hc550 respiratory humidifier was damaged.The insulation and copper wires were exposed.There was no patient consequence reported.

• Brand Name: RESPIRATORY HUMIDIFIER
• Common Device Name: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8342128
• Report Number: 9611451-2019-00120
• Device Sequence Number: 2285098
• Product Code: BTT
• UDI-Device Identifier: 09420012416810
• UDI-Public: 09420012416810
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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
• Operator of Device: Health Professional
• Device Model Number: HC550JHU
• Device Catalogue Number: HC550JHU
• Device Lot Number: 2100480246
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1