MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO GOBED II; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number FL28EX

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

It was reported the bed allegedly caught on fire where the mattress plugs into the bed.There was patient involvement, but no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported the bed allegedly caught on fire where the mattress plugs into the bed.There was patient involvement, but no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported the bed allegedly caught on fire where the mattress plugs into the bed.There was patient involvement, but no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Follow-up submitted with evaluation results which determined the alleged thermal event at the auxiliary outlet was due a broken mattress power plug power prong.Bed and mattress were replaced.

• Brand Name: GOBED II
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: rita moffitt ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4649210
• MDR Text Key: 5679822
• Report Number: 0001831750-2015-00156
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2015

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: FL28EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 04/01/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/30/2015; 07/31/2015
• 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