IPV-1C *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-16 for IPV-1C * manufactured by Percussionaire Corporation.

Event Text Entries

[19733128] Respiratory treatment was briefly started (<10 seconds) when high pressures occurred using the intrapulmonary percussive ventilator (ipv) machine. The patient's heart rate dropped to approximately 30 beats-per-minute and immediately returned to normal within 5 seconds. The nurse witnessed the event. Staff further tested the unit and high pressures were noted and the machine was not used further. Called for other respiratory therapists (rt's) to look at the unit and they also failed to see anything obviously wrong with the setup. This ipv medical treatment was skipped as another unit was not available. Clinical engineering states that there was a hard failure inside the machine that caused the high pressure. Machine returned to manufacture. Manufacture repair notes indicate "regulator creeps and regulator ring is broken, needs replaced. Metering valve goes up to fast and slow when pushed on the stem, needs replaced. Adjustable bulk head needs replaced. "======================manufacturer response for ipv machine, ipv-1c (per site reporter). ======================see repair note in event section. What was the original intended procedure? Ipv respiratory treatment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2950185
• MDR Report Key: 2950185
• Date Received: 2013-01-16
• Date of Report: 2013-01-16
• Date of Event: 2012-11-29
• Report Date: 2013-01-16
• Date Reported to FDA: 2013-01-16
• Date Reported to Mfgr: 2013-02-08
• Date Added to Maude: 2013-02-08
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IPV-1C
• Generic Name: DEVICE, POSITIVE PRESSURE BREATHING
• Product Code: NHJ
• Date Received: 2013-01-16
• Returned To Mfg: 2013-01-02
• Model Number: IPV-1C
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 8 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PERCUSSIONAIRE CORPORATION
• Manufacturer Address: P.O. BOX 817 SANDPOINT ID 83864 US 83864

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-01-16