MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOGEL 2860 W/MEDSURG FRAME; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number 2860000997

Device Problems Break (1069); Moisture Damage (1405)

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

Event Date 06/10/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the mattress had fluid intrusion due to a damaged cover.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was initially reported that the mattress had fluid intrusion due to a damaged cover.Follow-up submitted as further investigation determined the top cover was stained and there was no evidence of fluid ingress.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.This issue is not likely to cause or contribute to serious injury or death if it was to reoccur.

Event Description

It was reported via repair work order that the mattress had fluid intrusion due to a damaged cover.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: ISOGEL 2860 W/MEDSURG FRAME
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3911459
• MDR Text Key: 4922884
• Report Number: 0001831750-2014-03129
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2014

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: 2860000997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 07/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2014
• 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