MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POSITIONPRO W/PENDANT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number 2920000000

Device Problem Material Integrity Problem (2978)

Patient Problem Pressure Sores (2326)

Event Date 03/31/2015

Event Type  Injury  

Event Description

It was reported there was a general concern by the customer which alleged pressure ulcers due to breakdown in the sacral regions of position pro mattresses has increased.

Manufacturer Narrative

Follow-up submitted with evaluation results which determined the support pressure on the mattress was not being set correctly based on patient weight.No product malfunction was alleged or found.

Event Description

It was reported there was a general concern by the customer which alleged pressure ulcers due to breakdown in the sacral regions of position pro mattresses has increased.

• Brand Name: POSITIONPRO W/PENDANT
• 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: 4799373
• MDR Text Key: 17629985
• Report Number: 0001831750-2015-00246
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2920000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/27/2015
• 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