MAUDE Adverse Event Report: COMPRESSION THERAPY CONCEPTS, INC. VASOPRESS PUMP; SLEEVE, LIMB, COMPRESSIBLE

Model Number N/A

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4).Device product code: jow.The device history record (dhr) for the vp500 vasopress pump with serial number (b)(4) review noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing.The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed.Product review of the vp500 vasopress pump performed by zimmer biomet surgical on october 02, 2019 revealed that the device had alarm fail on low side.Additional product evaluation was performed by zimmer biomet surgical on november 25, 2019 since the original evaluation performed on october 02, 2019 did not provide the exact failure observed during evaluation is unclear.Product review performed on november 25, 2019 revealed that the device power cord was cut exposing wires and insulation was split on power cord.Repair of the vp500 vasopress pump was not performed due to the device being scrapped after product evaluation.The reported event "the device was broken" was confirmed since product review performed on november 25, 2019 revealed that the device power cord was cut exposing wires and insulation was split on power cord.A definitive root cause of the broken device could not be determined with the provided information since the cause for power cord damage is unknown.The device was scrapped after evaluation.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Review of the information provided during the investigation determined there is no further actions needed at this time (ie/capa/scar/hhe/d).Patient impact was requested but not provided by the customer.This complaint will be tracked and trended for any adverse trends that may warrant further action.

Event Description

It was reported that unit was broken.During investigation of the device, it was discovered that there were frayed and exposed wires on the device.No adverse events were reported as a result of this malfunction.

• Brand Name: VASOPRESS PUMP
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COMPRESSION THERAPY CONCEPTS, INC.; 555 industrial way w; eatontown NJ 07724
• Manufacturer (Section G): COMPRESSION THERAPY CONCEPTS, INC.; 555 industrial way w; eatontown NJ 07724
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46580 ; 5745273773
• MDR Report Key: 9454044
• MDR Text Key: 219217553
• Report Number: 3002834373-2019-00004
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991038
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: VP500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2019
• 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: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1