MAUDE Adverse Event Report: GRAND HEALTHCARE CO., LTD. CARE GUARD PUMP AND PAD 9153633206; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number CG9701

Device Problem Inflation Problem (1310)

Patient Problem Hip Fracture (2349)

Event Type  Injury  

Manufacturer Narrative

The injury allegation of broken hip with medical intervention of surgery reported has a harms and severity score of 3; therefore, the injury alleged is an fda reportable event.The product malfunction allegation of the mattress overlay is partially inflating is not likely to cause harm with a harms and severity score of greater than 2; therefore, the malfunction alleged is not an fda reportable event.The report of a cg9701 mattress overlay partially inflating does not pose any potential harm to the user as the height is 2.5 inches.The mattress overlay is designed with a to be placed over an existing mattress to mitigate any issues should the air completely leak out.Glossy sell sheet review 11-220 111226: (page 1) the cg9701 mattress overlay is designed to be placed on top of an existing mattress.(page 2) the cg9701 mattress overlay dimensions are 80" l x 34" w x 2.5" h.User¿s manual review (1074240 rev.1, page 2) note: there should be a cushion of air between the pad and the mattress of the bed.If not, check pump and pad for leaks, tears, kinks, or breaks.If damage is found, do not use.Contact carrier/dealer for further instructions.

Event Description

The reporter states her neighbor's mattress overlay is partially inflating.Reporter states there is air only coming out of one of the tubes from the power unit.No alleged injuries.No other information was available.Update from (b)(6) 2016 the end user called back in stating that back in (b)(6) 2014 since that the mattress was not working properly it caused her to fall out of the bed and break her hip.The end user stated that she had to have hip surgery because of this.The end user stated that only one of the two tubes that distribute the air into the pad are working.The end user stated that she has a hospital bed with a gel mattress on it and then the overlay is on top of the mattress.

Manufacturer Narrative

The injury allegation of broken hip with medical intervention of surgery reported has a harms and severity score of 3; therefore, the injury alleged is an fda reportable event.The product malfunction allegation of the mattress overlay is partially inflating is not likely to cause harm with a harms and severity score of greater than 2; therefore, the malfunction alleged is not an fda reportable event.The report of a cg9701 mattress overlay partially inflating does not pose any potential harm to the user as the height is 2.5 inches.The mattress overlay is designed with a to be placed over an existing mattress to mitigate any issues should the air completely leak out.Glossy sell sheet review (b)(4): the cg9701 mattress overlay is designed to be placed on top of an existing mattress.The cg9701 mattress overlay dimensions are 80" l x 34" w x 2.5" h.User¿s manual review (1074240 rev.1, page 2) note: there should be a cushion of air between the pad and the mattress of the bed.If not, check pump and pad for leaks, tears, kinks, or breaks.If damage is found, do not use.Contact carrier/dealer for further instructions.

Event Description

Product was returned for evaluation.The return fields in oracle state: therapeutic support surfaces.Power unit, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was confirmed for the pump only operating out of one of the outlet ports at a time.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.The reporter states her neighbor's mattress overlay is partially inflating.Reporter states there is air only coming out of one of the tubes from the power unit.No alleged injuries.No other information was available.Update from 3/24/16 the end user called back in stating that back in (b)(6) 2014 since that the mattress was not working properly it caused her to fall out of the bed and break her hip.The end user stated that she had to have hip surgery because of this.The end user stated that only one of the two tubes that distribute the air into the pad are working.The end user stated that she has a hospital bed with a gel mattress on it and then the overlay is on top of the mattress.

• Brand Name: CARE GUARD PUMP AND PAD 9153633206
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): GRAND HEALTHCARE CO., LTD.; 4f, no. 49, sec.2; jen ai road; taipei ; TW
• MDR Report Key: 5534160
• MDR Text Key: 41418397
• Report Number: 1531186-2016-00009
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 03/29/2016,05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CG9701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2016
• Distributor Facility Aware Date: 05/20/2016
• Device Age: 5 YR
• Date Report to Manufacturer: 03/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization