MAUDE Adverse Event Report: RESPIRONICS INC. PHILIPS RESPIRONICS CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2022

Event Type  Injury  

Event Description

We (b)(6) are a 3rd party contractor that repairs medical equipment in (b)(6).Our customers cannot get their recalled cpap device's fixed.The process's to repair these devices are in motion, (b)(6) would like to help coordinate the following fda recall's [i] the unit is a resmed (ref 37060) cpap device that provides support for a patient with sleep apnea.The motor is faulty.And we cannot repair this medical device; due to lack of physical availability of the replacement part, noting the replacement parts are not yet manufactured and there is a backlog.Do we (b)(6) have a means to communicate with the insurance entity associated with the issuance of a class ii medical device? [ii] as a 3rd party contractor available to repair these devices - the number of affected cpap devices is also coupled with another recall from philips respironics - which puts our customer in a terrible bind.It is the case that her partners cpap machine will continue to not-work until the insurance entity associated with the device is informed of where in the world the device physically is, and then, makes the connection (after the replacement part is manufactured and available) to allow the broken device to be fixed.We would like to help the translation of affected units serial numbers, to physical locations (here in (b)(6)) and thereby assist in capturing and repair of recalled devices - through the local network of biomedical engineers available on the islands.Any feedback regarding collaboration, please advise.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS INC.
• MDR Report Key: 13282592
• MDR Text Key: 284150992
• Report Number: MW5106693
• Device Sequence Number: 2
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/12/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Race: White