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

Catalog Number 2920100000

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 03/30/2014

Event Type  malfunction  

Event Description

It was allegedly that the patient's breathing tube began to come out as a result of the mattress turning.Allegedly, the nurses had to intervene, but the specific action was not explained.

Manufacturer Narrative

It was confirmed with customer that there was no reported patient injury or medical intervention needed.Further there was no defect found with mattress and it was operating to specifications.

Event Description

It was allegedly that the patient's breathing tube began to come out as a result of the mattress turning.Allegedly the nurses had to intervene, but the specific action was not explained.

• Brand Name: POSITIONPRO WITH 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3778508
• MDR Text Key: 4437827
• Report Number: 0001831750-2014-02942
• 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: 04/04/2014

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: 2920100000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2014
• Initial Date FDA Received: 04/29/2014
• 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