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

Catalog Number 2040000000

Device Problems Break (1069); Sticking (1597); Electrical Shorting (2926); Noise, Audible (3273)

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

Event Date 01/08/2014

Event Type  malfunction  

Event Description

It was reported that the lift was stuck elevated and making a noise due to damaged motor.It was also reported that the power cord was damaged causing a short.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the lift was stuck elevated and making a noise due to damaged motor.It was also reported that the power cord was damaged causing a short.It was further reported the litter wire harnesses were found to have damage with signs of burning and arcing.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Supplemental report submitted as the investigation also found that the litter wire harnesses were found to have damage with signs of burning and arcing.

• Brand Name: ZOOM 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: 3655825
• MDR Text Key: 4350988
• Report Number: 0001831750-2014-01966
• 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: 01/08/2014

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: 2040000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 03/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2014
• 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