MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO AIR EXPRESS APM; BED, FLOTATION THERAPY, POWERED

Catalog Number C1000DF

Device Problems Smoking (1585); Sparking (2595)

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

Event Date 10/28/2014

Event Type  malfunction  

Event Description

It was reported by the customer that the pump smoked and sparked when it was turned on.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported by the customer that the the pump smoked and sparked when it was turned on.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Evaluation and investigation concluded that the controller power cord iec connector area became damaged causing a break in a wire and smoke to emit from the area.

• Brand Name: AIR EXPRESS APM
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4300542
• MDR Text Key: 5058307
• Report Number: 0001831750-2014-03382
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2014

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: Other
• Device Catalogue Number: C1000DF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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