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

Catalog Number 2920500000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2018

Event Type  malfunction  

Event Description

It was reported the power cord had bent power prongs.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: POSITIONPRO W/O 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7537326
• MDR Text Key: 109238284
• Report Number: 0001831750-2018-00496
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 07613327277746
• UDI-Public: 07613327277746
• 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
• Report Date: 05/23/2018

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: No Information
• Device Catalogue Number: 2920500000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2010
• 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