MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STRYKER AIR PUMP, AFTERMARKET; BED, FLOTATION THERAPY, POWERED

Catalog Number 2861000002

Device Problem Defective Component (2292)

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

Event Date 02/20/2014

Event Type  malfunction  

Event Description

It was reported that the power cord had exposed wires where cord connects to pump.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the power cord had exposed wires where cord connects to pump.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Power cord on order.

Manufacturer Narrative

Initial medwatch report submitted in error.Tridien, the manufacturer of the product, is responsible for all regulatory reporting and complaint handling and closure.This complaint was sent to tridien for handling.

• Brand Name: STRYKER AIR PUMP, AFTERMARKET
• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3679171
• MDR Text Key: 4242944
• Report Number: 0001831750-2014-02310
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2014

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: 2861000002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2014
• Initial Date FDA Received: 03/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/15/2014
• 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