MAUDE Adverse Event Report: PRECISION MEDICAL INC MAXTEC MICROMAX; MICROMAX LOW FLOW BLENDER

Model Number PM5300ENMX

Device Problem Fire (1245)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Precision medical inc shipped micromax blender (sn (b)(4)) on 12/04/2018 to maxtec (private label distributor).12/17/2019 - maxtec notified precision medical inc of a fire involving a micromax blender (sn (b)(4)) in (b)(6).Maxtec indicated the fire was due to an issue with the regulator (an external source).The regulator was not supplied by precision medical inc.12/19/2019 - precision medical contacted maxtec to obtain additional information to be provided for precision medical inc to perform an internal investigation a follow-up report will be submitted once precision medical inc receives additional information and involved products from maxtec.As of (b)(6) 2019 precision medical inc has received a fire incident - service report indicating the incident was due to a faulty regulator not supplied by precision medical inc.12/19/2019 - documentation in reference to the incident received from maxtec and requested of maxtec is attached to this report.

Event Description

Information formally provided: on (b)(6), our vendor was in nicu dept for installation of bubble cpap with maxtec blender, after installation, vendor was having final checking or trial of proper functioning of cpap device, with a flow of 10 liter.Suddenly the blender got burst of fire.There was no injury to hospital staff, patients.Our channel partner met with a superficial burn of his left hand and got immediately first aid treatment from the hospital.Additionally information yet to be verified indicates a slightly different sequence of events.Also, failure (regulator - not supplied by precision medical inc) of additional equipment in the gas supply circuit.Neither changing the end results.

Event Description

Maxtec (private label distributor) received the information below from their customer f&p in india.Information formally provided: on 26th nov, our vendor was in nicu dept for installation of bubblecpap with maxtec blender, after installation, vendor was having final checking or trial of proper functioning of cpap device, with a flow of 10 liter.Suddenly the blender got burst of fire.There was no injury to hospital staff, patients.Our channel partner met with a superficaial burn of his left hand and got immeditaley first aid treatment from the hospital addtionally information yet to be verified indicates a slightly different sequence of events.Also, failure (regulator - not supplied by precision medical inc) of additional equipment in the gas supply circuit.Neither changing the end results.

Manufacturer Narrative

02/05/2020 - notification from maxtec confirmed device is not being returned from distributor "fisher & paykel helathcare" for additional investigation.Precision medical inc received a incident - service report from fisher & paykel healthcare (fph complaint ps:327095) which concludes the cause was due to a faulty pressure gauge/regulator connected on cylinder.Regulator was not manufactured or supplied by precision medical inc.

• Brand Name: MAXTEC MICROMAX
• Type of Device: MICROMAX LOW FLOW BLENDER
• Manufacturer (Section D): PRECISION MEDICAL INC; 300 held drive; northampton PA 18067
• MDR Report Key: 9505546
• MDR Text Key: 172282104
• Report Number: 2523148-2019-00002
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 00853061006074
• UDI-Public: 00853061006074
• Combination Product (y/n): N
• PMA/PMN Number: K053232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/17/2019,02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM5300ENMX
• Device Catalogue Number: PM5300ENMX
• Device Lot Number: 12031800031
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2019
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention