MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO EPIC II CRITICAL CARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 2030000000

Device Problems Bent (1059); Sticking (1597); Malposition of Device (2616)

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

Event Date 01/03/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the footend was stuck in an elevated position due to bent base and faulty lift mechanism.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Conclusion: found bed in disrepair.Awaiting further instructions.

• Brand Name: EPIC II CRITICAL CARE BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3585305
• MDR Text Key: 4143197
• Report Number: 0001831750-2014-00661
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2014

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: 2030000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/03/2014
• Initial Date FDA Received: 01/21/2014
• 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