MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR, LLC ACROBAT-I POSITONER; DXC

Model Number XP-5000

Device Problem Moisture Damage (1405)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

The customer reported that when the big shipping box was opened, one xp-5000 on bottom of shipping box had water damage on the xp-5000.The seepage was potentially through the fedex box.The device could not be sold as is.

Manufacturer Narrative

The device was returned to the factory for eval.The outer box showed a stained area along the bottom of the carton.The cardboard was warped in the area.The tubing set packaging showed foreign material/dirt on the tyvek closet to the bottom of the box in the same are as the carton damage.The rest of the device packaging was undamaged.Based on the condition of the device as returned, we are able to confirm the reported complaint for "water damage/shipping." the device eval is in progress.A supplemental will be forwarded when more info becomes available.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.There are no other similar complaints reported against this batch.(b)(4).

• Brand Name: ACROBAT-I POSITONER
• Type of Device: DXC
• Manufacturer (Section D): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CARDIOVASCULAR, LLC; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4652316
• MDR Text Key: 5681289
• Report Number: 2242352-2015-00243
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2015

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 Expiration Date: 12/01/2016
• Device Model Number: XP-5000
• Device Lot Number: 25107284
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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