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

Catalog Number 2141000000

Device Problems Failure to Power Up (1476); Low Battery (2584)

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

Event Date 01/06/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the bed had no power due to low battery.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported via repair work order that the bed had no power due to low battery.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was initially reported that the bed had no power due to low battery.Follow-up submitted as further investigation determined his is not likely to harm the patient as the only bed function that requires the battery is the zoom.The bed can be moved manually by the caregiver.No patient was affected and no adverse consequences or clinically relevant delays in treatment were reported.This issue is not likely to contribute to or cause serious injury or death if it were to recur.

• 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: 3581668
• MDR Text Key: 4032111
• Report Number: 0001831750-2014-00525
• 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: 01/06/2014

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: 2141000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2014
• Initial Date FDA Received: 01/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2014
• 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