MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CONTROL UNIT AAS 120V; BED, FLOTATION THERAPY, POWERED

Catalog Number C2500MS

Device Problem Break (1069)

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

Event Date 11/18/2013

Event Type  malfunction  

Event Description

It was reported that there was no power to the unit due to a damaged inlet filter.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was initially reported the unit had a damaged power plug.Further investigation found that the unit had no power due to a damaged inlet filter.The issue of no power to the control unit is an annoyance issue only, as it would be apparent that the unit was not functional, and additionally, the patient would still be submitted by the support surface of the mattress.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.This issue is not likely to cause or contribute to serious injury or death if it were to recur.

Event Description

It was reported that the power plug was damaged.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: CONTROL UNIT AAS 120V
• 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3626757
• MDR Text Key: 4430053
• Report Number: 0001831750-2014-01285
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/21/2014

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: C2500MS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: No
• 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