MAUDE Adverse Event Report: PRECISION MEDICAL INC. EASY GO VAC; PUMP.PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number PM65

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 04/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Subject: easy go aspirator serial # (b)(4).Med watch: (b)(4).Dear (b)(6), the pm65 serial number (b)(4), found with a broken power jack.The history on the device is that it was manufactured in october of 2004, and precision medical shows no record of the device being returned for repair.The device is 12 years old, or twice the recorded life of the product.The likely cause of the complaint, is that the male connector that mates with the device was forced into the connector, braking the female internal power connector.This happens as a result of dropping the device, or the age of the device caused the socket to fail.I would recommend that all pm65 aspirators be checked for this reason, to be sure that the internal battery is being charged.The life of the pm65 aspirator is 5 years.The warranty of the pm65 is 2 years.The life cycle of a lead acid battery is approximately 2 years.I would also recommend that pm65 devices, twice the average life span, be considered for replacement.Any other questions please feel free to contact me.Regards, (b)(4), quality manager, precision medical inc.(b)(4).

Event Description

Event description: audit completed by biomed.Approximately 2 months ago -2 other precision pm65 suction machines not functioning correctly, with same issue, found in 2 different units.An audit at sister hospital # 1 found 2 portable suction machines not functioning correctly.No defective units found at sister hospital # 2 as of 2 weeks after initial audit.Power adapter connector was found to be broken internally preventing charging of the battery or use when plugged into a ac outlet.This indication would not be observable from the outside of the device.The connector will be replaced.During further investigation of our fleet of portable suctions: two additional devices were found with the same issue; these two will be repaired.The two suction mentioned at sister hospital #1 were a different issue; they had the wrong voltage charger.

• Brand Name: EASY GO VAC
• Type of Device: PUMP.PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): PRECISION MEDICAL INC.; 300 held drive; northampton PA 18067
• Manufacturer (Section G): PRECISION MEDICAL INC; 300 held drive; northampton PA 18067
• Manufacturer Contact: james parker ; 300 held drive; northampton, PA 18067 ; 6102626090
• MDR Report Key: 5986779
• MDR Text Key: 56544743
• Report Number: 2523148-2016-00002
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: PM65
• Device Catalogue Number: PM65
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2016
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2016
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EASY GO VAC
• Patient Outcome(s): Other