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

Catalog Number 2140000000

Device Problem Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 08/03/2016

Event Type  Injury  

Event Description

It was alleged that there was a sudden loss of zoom function causing the nurses to have to push the beds manually, which allegedly caused a back injury to a nurse.It was reported that the injured nurse visited a clinician and was put on light duty.

Manufacturer Narrative

Customer unable to identify which unit caused the event.Therefore stryker was unable to evaluate the bed to verify root cause of loss of zoom function.Customer unable to identify which unit caused the event.

Event Description

It was alleged that there was a sudden loss of zoom function causing the nurses to have to push the bed manually, which allegedly caused a back injury to a nurse.It was reported that the injured nurse visited a clinician and was put on light duty.The customer was unable to confirm which unit had experienced the issue, so stryker was unable to evaluate the bed in order to confirm the root cause of the event.

• Brand Name: IN TOUCH ZX
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5915930
• MDR Text Key: 53549536
• Report Number: 0001831750-2016-00276
• 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: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2140000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• 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