MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO IN TOUCH EU; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 2131000000

Device Problems Break (1069); Device Sensing Problem (2917)

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

Event Date 03/04/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the bed had a base sensor error due to a faulty wiring harness.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: IN TOUCH EU
• 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: 3702074
• MDR Text Key: 4247699
• Report Number: 0001831750-2014-02685
• 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: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2131000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2014
• 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