MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO C2500MS & M2500 LAL/APM; BED, FLOTATION THERAPY, POWERED

Catalog Number P2500

Device Problem Smoking (1585)

Patient Problem Discomfort (2330)

Event Date 04/25/2015

Event Type  malfunction  

Event Description

It was reported that the mattress deflated due to the pump stopping and smoking.This caused the patient discomfort so they were moved onto another surface.During transport a bed sore allegedly opened up requiring treatment.

Manufacturer Narrative

Follow-up submitted with evaluation results provided by the distributor which determined the pump malfunctioned and they are working with the customer to replace it.Distributor performed evaluation.

Event Description

It was reported that the mattress deflated due to the pump stopping and smoking.This caused the patient discomfort, so they were moved onto another surface.During transport, a bed sore allegedly opened up requiring treatment.

• Brand Name: C2500MS & M2500 LAL/APM
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: 5457972
• MDR Text Key: 39350073
• Report Number: 0001831750-2016-00066
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2016

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: No Information
• Device Catalogue Number: P2500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• 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