MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED ADULT HUMIDIFICATION CHAMBER; BTT

Model Number MR210

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint mr210 adult humidification chambers have arrived at fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow-up report once we have completed our investigation.

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the domes of two mr210 adult humidification chambers were cracked when the packaging was opened.This was observed before use on a patient.

• Brand Name: ADULT HUMIDIFICATION CHAMBER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216
• MDR Report Key: 3575649
• MDR Text Key: 21270978
• Report Number: 9611451-2014-00038
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR210
• Device Catalogue Number: MR210
• Device Lot Number: 130222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2014
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1