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

Catalog Number 2141000000

Device Problems Device Slipped (1584); Naturally Worn (2988)

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

Event Date 02/04/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the right side rail would not lock due to a worn latch and a broken weldment.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was initially reported that the right side rail would not lock due to a worn latch.Follow-up submitted as further investigation determined the siderail not locking was also due to a broken weldment.

Event Description

It was reported via repair work order that the right side rail would not lock due to a worn latch.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: IN TOUCH ZU
• 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: 3650050
• MDR Text Key: 4250906
• Report Number: 0001831750-2014-01813
• 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,Followup
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2141000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2014
• 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